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Global Research

Healthcare India Pharmaceuticals


Equity India

Generic Launch Calendar V


Lupin, Cadila among first-filers on Pfizers Pristiq
New ANDA filings by Indian generics: Lupin and Cadila on Pristiq, Cadila on Gralise, and Ranbaxy on Atelvia Osmotica files yet another citizen petition on Effexor XR 225 mg against Sun Pharma Teva saves Copaxone against generics from Sandoz/ Momenta and Mylan/ Natco

We highlight updates on new filings across our coverage universe and key litigation updates on existing product pipeline. Please see below for detailed launch calendar.

New ANDA filings


Lupin (LPC IN, OW, TP INR610) and Cadila (CDH IN, OW, TP INR 860): 27 June 2012
Girish Bakhru*, CFA Analyst HSBC Securities and Capital Markets (India) Private Limited +91 22 2268 1638 girishbakhru@hsbc.co.in Damayanti Kerai* Associate Bangalore

Pristiq (desvenlafaxine succinate): Lupin and Cadila have filed ANDAs on Pfizers antidepression drug Pristiq. Watson is another known filer on the drug. Innovator has sued these three players for infringement of single patent 838 covering Pristiq, which has an expiration date of 11 February 2022. Generic launch is currently blocked by a 30-month stay until 29 August 2015. We believe all three are potential first filers and are entitled for 180 days of exclusivity. Pristiq was approved by the US FDA on 29 February 2008 and it recorded 12-months sales of USD560m for period ending April 30 2012. Pristiq, which is desvenlafaxine, is the active metabolite of Effexor XR. Wyeth has been effectively trying to shift prescriptions to Pristiq since Effexor went generic. While both have the same active metabolite (venlafaxine), Pristiq has been reported to have lesser side effects and doesnt require slow titration at the start of the treatment. Lupin FTF status on Pristiq along with possible other filers is something we communicated earlier in our note - 1QCY12 DMF filings, dated 20 April 2012. Cadila (CDH IN, OW, TP INR 860) Gralise (extended release gabapentin): Depomed has sued Zydus Cadila for patent infringement on its pain-relieving drug, Gralise. Cadila was sued along with Impax, par, Actavis, Watson and Incepta for both strengths of 300 and 600mg. Gralise is a recent launch in US (launched on 10 October 2011) with annual brand sales still less than US100m. However, drug dosing profile of Gralise is favourable against other pain medicines like Neurontin and Lyrica, hence we expect brand sales to grow.

View HSBC Global Research at: http://www.research.hsbc.com

Issuer of report:

HSBC Securities and Capital Markets (India) Private Limited

*Employed by a non-US affiliate of HSBC Securities (USA) Inc, and is not registered/qualified pursuant to FINRA regulations

Disclaimer & Disclosures This report must be read with the disclosures and the analyst certifications in the Disclosure appendix, and with the Disclaimer, which forms part of it

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

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As per Orange Book, Gralise is covered by six patents with expiration date between September 2016 and February 2024. Given multiple filers we do not see this as a great commercial opportunity as of now. Ranbaxy (RBXY IN, UW, TP INR472) Atelvia (reformulated risedronate sodium): Ranbaxy was sued by Warner Chilcot on its osteoporosis drug Atelvia (annual US sales of USD45mn), which is advanced formulation of risendronate sodium sold as popular brand Actonel. Atelvia has new drug formulation (NDF) exclusivity until October 2013. Ranbaxy seems to be the second filer on the drug, the first being Teva. The earliest patent expiry for the drug is in June 2014, while two dose formulation patents dont expire until 2028. Given the small brand size of the drug, this is not a very material opportunity for Ranbaxy though this ANDA filing is a para-IV filing for Ranbaxy after a long-haul due to FDA manufacturing issues at its Himachal facilities.

Other key litigation developments


Teva emerges victorious in Copaxone (glatiramer) litigation On 23 June 2012, the US District Court for the Southern District of New York has ruled in favour of Teva in its litigation against Sandoz/Momenta and Mylan/Natco and thus prohibiting any generic Copaxone launch until 24 May 2014 when the patents covering the drug expires. Teva further stated its belief that these companies cannot launch their generic Copaxone until the process patent expires on 1 September 2015. This was big setback for Natco Pharma, which has significant opportunity in this product along with Mylan. Apotex sues Lupin on quinapril process Quinapril tablets: Apotex Pharma has filed a litigation against Lupin in US District Court of Florida citing infringement of 486 patent covering pharmaceutical composition of quinapril tablets indicated for hypertension. Patent 486 patent was issued to Apotex in 2003 and it is related to processes for making solid formulations of quinapril. Quinapril is already sold as generics by many players; Apotex has sued Lupin upon belief that Lupin is infringing on its patented process for manufacturing quinapril. Given quinapril is just cUSD5m product for Lupin, we believe this litigation is not material for Lupin. Osmotica files yet another CP against Sun Pharma on Effexor XR Osmotica has filed a CP with the FDA against Sun Pharma asking FDA for not approving Sun Pharmas ANDA on Effexor XR (venlafaxine HCl) 225mg tablet if the tablet size is considerably larger than size of the reference listed drug (RLD). Currently, Sun Pharma sells generic version of Effexor XR in 37.5mg, 75mg and 150mg. Sun had filed for ANDA on 225mg strength on 7 January 2011. Sun had received for currently sold strengths in August 2010 and these strengths are referenced against Osmoticas venafaxine tablets. As per CP, Osmotica expressed concern that size of Suns 225mg tablet may be considerably larger than RLD and hence potentially unsafe to use. Additionally, given large size of the tablet may cause local irritation as it disintegrates and may be associated with higher case of dyspepsia, heartburn. The overall size of the venlafaxine tablet market is cUSD130-150mn of which 225mg strength is cUSD35-40mn which makes this a sizeable opportunity for Suns base business. We believe case for

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

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petition grant is weak given similar technology used to make 225mg strength has been approved in earlier strengths. With entry in 225mg strength, Sun will participate in entire venlafaxine tablet market and can add cUSD8-10mn in its annual base generic sales. Sandoz files CP seeking forfeiture of Ranbaxys Nexium exclusivity Sandoz has filed a CP with the US FDA stating Ranbaxy failed to obtain tentative approval within 30 months of its ANDA filing on Nexium and hence its exclusivity should be forfeited. Ranbaxy is the firstto-file on AstraZenecas blockbuster GERD drug Nexium and has already settled with the innovator for a generic launch in May 2014. Sandoz stated that since Nexium is a post MMA (Medicare Modernization Act of 2003) filing, it must obtain tentative approval within 30 months of submission of its ANDA filing to retain its exclusivity. As per CP, Ranbaxy filed ANDA on Nexium on 5 August 2005 and it should have obtained tentative approval by 4 February 2008 but it has obtained approval on 5 February 2008. We believe the Sandoz argument on the delay of tentative approval by a day appears weak and FDA may not pay much attention to it. Nonetheless, the CP adds uncertainty to the product. For details please refer to our note, Sandoz says Ranbaxy forfeits Nexium FTF dated 27 June 2012.

Dr Reddys Lab: Key Generics Expected Timeline


Generic Launch Calendar V India Pharmaceuticals 27 June 2012

Molecule Atorvastatin Clopidogrel Desloratadine

Brand Lipitor Plavix Clarinex

Indication High Cholesterol Blood Thinner For ACS Anti-Histamine

Sales (USD mn) Who is FTF? 5,329 5,961 249 Ranbaxy

Timeline Remarks Delayed

Ibandronate Finasteride Pioglitazone Montelukast Rosiglitazone Esomeprazole magnesium+naproxen Rabeprazole Eszopiclone Moxifloxacin Valganciclovir Esomeprazole Memantine Palonosetron Naproxen + Sumatriptan Fenofibrate Dexlansoprazole Bivalirudin Montelukast Total
Source: Company data, HSBC

Boniva Proscar Actos Singulair Avandia Vimovo Aciphex Lunesta Avelox Valcyte

Osteoporosis Male Pattern Baldness Type-2 Diabetes Asthma/Allergic Rhinitis Diabetes Osteoarthritic Pain GERD Insomnia Anti-Infective Cytomegalovirus infections

506 148 3,212 3,219 300 50 1,000 783 350 400

Ranbaxy launched with Watson AG as per base assumption. Mylan, Apotex and Sandoz entered at end of FTF. DRL expected, but approval is delayed. Actavis, Kudco, Aurobindo, McLeods are other filers Apotex (Lost) Launched Apotex did an at risk launch in 2006 for which it recently payed USD 551mn penalty, has likely lost exclusivity. Paediatric exclusivity expires on 17th May 2012 Multiple Jul-12 not a significant opportunity due to multiple filers. On Reditabs filers are few but sales are small as well. Dr Reddy has co-exclusivity, will launch in early 2012. DRRD has final approval as well. Orchid has settled too. Cadila is a another filer Multiple Sep-12 Shared FTF Dr Reddy Jan-13 Likely to be recurring Ranbaxy, Mylan, Watson Feb-13 Dr Reddy's enter post FTF in a crowded market. Teva is AG Teva Feb-13 Teva lost in first round to Merck. Teva FY13 Teva settled with GSK, to launch in 1Q2012 Dr. Reddy's? Unknown Exclusivity to expire on April 30, 2013; Dr Reddy's might be first-to-file status. Lupin is other filer May-13 Multiple Nov-13 Mar-14 Mar-14 Single patent expiring in May 2013. Generics can enter post that. Dr Reddy and Teva had filed ANDAs but lost. Unlikely to see a pre patent expiry generic launch. Not meaningful if everyone enters post May Lupin, Teva, Glenmark, Orchid have settled, others may settle as well. Peads exclusivity may push opportunity to May-14 Dr Reddy lost the case, launch will be after March 14 patent expiry 30-months expiry on Jun-14; Ranbaxy, Sandoz, Endo, Apotex were also sued, Ranbaxy settled for Mar13 Settled, will likely enter with Teva post Ranbaxy FTF period. Sandoz has settled too. Lupin is another filer Settled, not a meaningful opportunity Injectable form is covered not capsule. Teva has settled. Par, Mylan and Dr Reddy's case is ongoing. Pozen had filed for PI against Par and recently was granted PI. Sun has filed too Lupin sold ANDA to Dr Reddy post acquisition of the brand, launch before patent expiries. Paddock, Ranbaxy, Apotex and Mylan are other filers Anchen has filed too Mylan and Hospira are other known filers. Base patent expires in Feb-12 but Teva settled for Jun-19 launch. Teva has no tentative approval yet though. Fresenius settled for May-19 launch as well Granule oral formulation, patent for packet expires in Oct 2022. Earliest launch can be through settlement or 30mth expires in Sep-14.

Dr Reddy Ranbaxy

Nexium GERD 2,695 Namenda Alzheimer'S Disease 600 Aloxi Chemotherapy Induced Nausea 500 And Vomiting Treximet Migraine 120 Antara High Cholesterol 60 300 400 70 20,291

Ranbaxy Nov-14 Multiple Jan-15 Dr Reddy, Sandoz, Teva Apr-15 Par Dr Reddy Handa Pharma, Impax? Teva, Fresenius Mylan 2017 Unknown Unknown Unknown Unknown

Dexilant Acid Reflux Angiomax Anticoagulant Singulair Asthma/Allergic Rhinitis

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Lupin: Key Generics Expected Timeline ( to be continued) Molecule venlafaxine XR Estradiol, levonorgestrel Estradiol, levonorgestrel Desloratadine Fenofibrate Repaglinide + metformin Drospirenone + Ethinyl estradiol Ciprofloxacin OS Drospirenone + Ethinyl estradiol Armodafinil Doxycycline Duloxetine Mesalamine Sevelamer carbonate Sevelamer hydrochloride Pregabalin Eszopiclone Niacin ER Choline fenofibrate Estradiol, norethindrone Estradiol, norethindrone Estradiol, norethindrone Valsartan + Amlodipine Esomeprazole Memantine Colesevelam Esomeprazole magnesium+naproxen Darunavir
Source: Company data, HSBC

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

Brand Effexor XR Seasonale Seasonique Clarinex TriCor Prandimet Yaz Cipro Yasmin Nuvigil Oracea Cymbalta Asacol Renvela Renagel Lyrica Lunesta Niaspan TriLipix Loestrin 24 Fe Lo Loestrin Fe Generess Exforge HCT Nexium Namenda Welchol Vimovo Prezista

Indication Depression Oral Contraceptive Oral Contraceptive Anti-Histamine High Cholesterol Type-2 Diabetes Contraception Anti-Bacterial Contraception Narcolepsy Rosacea MDD Depression Ulcerative Colitis Chronic Kidney Disease Chronic Kidney Disease Anti-Convulsant Insomnia High Cholesterol High Cholesterol Oral Contraceptive Oral Contraceptive Oral Contraceptive Hypertension GERD Alzheimer'S Disease High Cholesterol Osteoarthritic Pain HIV

Who is FTF? Sales (USD mn) 2,499 45 60 249 1,578 10 330 200 100 200 250 2,772 500 330 377 1,424 783 1,000 300 250 20 10 2,695 600 300 50 400 Teva Generic Watson Multiple Teva (lost) Sandoz, Actavis Teva Lupin Teva Multiple Mylan Multiple Roxane Impax Lupin Multiple Multiple Teva Impax Watson Lupin Mylan Ranbaxy Multiple Impax tabs/ Lupin susp. Dr. Reddy's? Lupin, Mylan

Timeline Remarks Delayed FY13 Jun-12 Jul-12 Sep-12 Dec-12 Dec-12 FY13? FY13 FY 13 May-13 Jun-13 Jul-13 Aug-13 Aug-13 Oct-13 Feb-14 Feb-14 Jul-14 Jul-14 Jul-14 FY15 Nov-14 Jan-15 Jun-15 Aug-15 Dec-15 Approval expected soon Already generic with Watson and Sandoz in market Already generic with Watson brand Amethia. Mylan has also filed not a significant opportunity Teva lost exclusivity given lack of tentative approval within 30mths. Ranbaxy and Impax are other filers The outcome is linked to decision on Prandin case Teva launched its generic under name "Gianvi"; Sandoz in market too. Watson, Sun, Mylan are other filers small opportunity Teva launched its generic under name "Ocella". Watson and Sandoz in market as well. Lupin awaiting approval 30mth expire in Sep-12. Teva, Mylan, Watson and Actavis are FTF. Sandoz, Apotex are other filers. Mylan has final approval but not launched yet. Lupin likely launch after 30mth in May-13. Impax, Sandoz other filers not a significant opportunity, given multiple filers Authorized Generic, assuming launch after exclusivity expiry for Roxane Lupin FTF on suspension. Watson and Sandoz filed on tablets too Sandoz, Impax, Endo are other filers. Lupin yet to receive tentative not a significant opportunity owing to intense competition Lupin, Teva, Glenmark, Orchid have settled. Paediatrics exclusivity may push opportunity to May-14 Teva had settled with Kos (under Abbott) for Sep 20, 2013 launch. Sandoz, Zydus, Mylan and Sun are other filers Watson, Sandoz and Actavis are other players. Impax settled for Jan-14 launch (July-13 in certain circumstances). Lupin, Watson and Mylan also have settled Settled for 22nd July 2014. Watson enters in Jan 2014 Lupin is likely the FTF on this drug Small opportunity Settlement likely? not a significant opportunity, given multiple filers 30mth expire in Jan-13 for both tab and susp. Compound patent expires in June 15. We assume late launch for now on tabs. Impax, Watson, Glenmark filed on susp too. Watson on tabs too. Early launch on suspension likely Lupin is sued on all patents unlike DRRD which is sued on late expiring patents Teva and Hetero are the recent filer

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Lupin: Key Generics Expected Timeline (continued) Molecule Darunavir Metformin ER Carvedilol CR Estradiol, norgestimate Gatifloxacin Gatifloxacin Abacavir + lamivudine + zidovudine Lapatinib ditosylate Ranolazine Moxifloxacin Calcium acetate Bimatoprost Ketorolac tromethamine Desvenlafaxine succinate Lanthanum Carbonate Total
Source: Company data, HSBC

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

Brand Prezista Glumetza Coreg CR

Indication

Who is FTF? Sales (USD mn) 400 70 300 450 Lupin, Mylan Lupin Mutual Teva Lupin Apotex Lupin Natco Pharma Lupin Teva Roxane Sandoz Generic Watson, Lupin, Zydus Natco, Teva, Mylan

Timeline Remarks Dec-15 Feb-16 Apr-16 May-16 Jun-16 Jun-16 FY17 Jun-17 May-19 Unknown Unknown Unknown Unknown Unknown Teva and Hetero are the recent filer Sole FTF, Sun is the other filer. Lupin has settled for 1 Feb 2016 launch. Lupin is the only other filer so far. Mutual filed in 80mg capsules in 2007 Teva to re-enter market in Dec-2015. Watson, Sandoz, Mylan and Sun are other filers 0.5% solution/drops, no other filer till date 0.3% solution/drops, Apotex is FTF Lupin is the only player sued so far, combination patent expires in 2016

HIV Type-2 Diabetes Hypertension, Heart Attack, Heart Failure OrthoTricyclen Lo Oral Contraceptive Zymaxid Bacterial Conjunctivitis Zymar Bacterial Infection of Eyes Trizivir HIV Breast Cancer Chronic Angina Pectoris Bacterial Conjunctivitis ESRD Gluacoma NSAID MDD Depression Chronic Kidney Disease

114 114 160 281 15 400 5 590 100 19,931

Tykerb Ranexa Vigamox PhosLo Lumigan Acular LS Pristiq Fosrenol

Multiple patents expiring on May 27th, 2019. Lupin yet to get tentative approval. Watson is the other filer Nabi sold the brand to Fresenius. Roxane has settled with Nabi. Cadila, Paddock are known filers Sandoz is FTF. Lupin filed on 0.01% sol. Expected launch after Aug-14. Already generic with Akorn, Sandoz and Apotex. Lupin can launch on approval. Single patent expiry in 2027 Single patent expiring in 2022. 30 month block till April 2015 for all first filers. We expect more competition to emerge slowly by time of launch Unknown Lupin has tie up with Natco for this. Alkem has filed too

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Ranbaxy: Key Generics Expected Timeline Molecule Minocycline Brand Solodyn Indication Acne Sales (USD mn) Who is FTF? 370 Impax, Teva, Sandoz, Mylan, Ranbaxy Timeline Remarks

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

Modafinil Desloratadine Pioglitazone Irbesartan/hctz Valsartan Fenofibrate Valganciclovir Oxycodone Pioglitazone + metformin Rivastigmine Esomeprazole Memantine Fenofibrate Alfuzosin Risedronate (Delayed release) Sirolimus Total
Source: Company data, HSBC

Provigil Clarinex Actos Avalide/Avapro Diovan TriCor Valcyte Oxycontin Actoplus met Exelon soln Nexium Namenda Antara Uroxatral Atelvia Rapamune

Narcolepsy Anti-Histamine Type-2 Diabetes Hypertension & CHF Hypertension & CHF High Cholesterol Cytomegalovirus Infections Moderate To Severe Pain Type-2 Diabetes Alzheimer'S Disease GERD Alzheimer'S Disease Hypercholesterolemia Benign Prostatic Hyperplasia Osteoporosis Immuno-suppressant

961 249 3,212 124 2,520 1,578 400 3,150 478 <5 2,695 600 60 200 45 200 16,842

Launch expected soon Ranbaxy has settled along with Teva, Impax, Mylan and Sandoz for 45mg,90mg,135 mg strength. Lupin and Aurobindo are other filers. Teva, Sandoz and Mylan had launched it earlier but then later settled for launch in Nov-11 Ranbaxy, Teva, Mylan Delayed Teva launched its generic. Ranbaxy had settled but FDA recently announced sole exclusivity for Teva. Mylan, Ranbaxy have not got approval - probably forfeited exclusivity Multiple Jul-12 not a significant opportunity Ranbaxy, Mylan, Watson Aug-12 Settled. Teva is AG. Multiple filers post exclusivity Teva Sep-12 Teva launched as FTF, Ranbaxy likely enter post exclusivity in Sep 2012 along with other generics Ranbaxy Sep-12 Ranbaxy had changed its Para IV to Para III and will launch post Sep-12 patent expiry Teva Oct-12 Teva is FTF on 145mg with settlement date on Mar-12. Other filers include Lupin, Impax and Wockhardt Ranbaxy Mar-13 Roche failed to prove that Ranbaxy's product was crystalline which was covered under patent '953. Ranbaxy claimed it had amorphous form. Sandoz, Apotex, Endo also sued on this product Ranbaxy, Teva, Endo Apr-13 Watson is the AG Mylan Jun-13 Mylan is FTF enters in Dec-12, Ranbaxy post 6 months of that along with 7 other plays Ranbaxy? Feb-14 Ranbaxy is Para III on '176 patent that expires in Feb-14. Very small product Ranbaxy May-14 Ranbaxy is FTF. DRL and Teva settled for Nov-14. Sandoz and Lupin are other filers. Multiple Jan-15 not a significant opportunity Dr Reddys Unknown DRL is FTF, Ranbaxy to launch post exclusivity. Paddock, Apotex and Mylan are other filers Multiple Unknown Ranbaxy was expected to enter post exclusivity in Jan-12 but didnt get approval so far. Already generic with more than 5 players in market Teva Unknown Base patent on Actonel also protects Atelvia till June 2014. Additional formulation patents run till 2028. We believe generic will not enter before 2014. Ranbaxy, Watson Unknown Ranbaxy settled with Pfizer, terms of settlement are unknown

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Sun Pharma: Key Generics Expected Timeline Molecule Oxaliplatin Brand Eloxatin Indication Colorectal Cancer Generalized Anxiety Disorder Allergic Rhinitis Allergic Rhinitis Parkinson'S Disease MDD Depression Sedative Medication Anti-Convulsant Insomnia Atopic Dermatitis And Psoriasis High Cholesterol Oncology Contraception Neuralgia Alzheimer'S Disease GERD Osteoporosis Sales (USD mn) Who is FTF? 1,400 2,259 100 215 100 2,772 150 1,424 783 40 1,000 403 330 15 600 50 800 2,592 1,285 450 2,640 500 390 51 200 100 50 120 400 21,219 Multiple Teva Teva Perrigo/Synthon Wockhardt Multiple Sandoz Multiple Multiple Glenmark Teva Teva Teva Sun Pharma Multiple Teva Teva Multiple Sun Pharma Teva Teva Teva Multiple Sun Pharma Sun Pharma Sun Pharma, Teva Lupin Par Teva, Fresenius Timeline Aug-12 Oct-12 FY13 FY13 Apr-13 Jun-13 Jul-13 Oct-13 Nov-13 Dec-13 Mar-14 Feb-14 FY14 May-14 Jan-15 FY15 FY15 Apr-15 Jul-15 May-16 Jul-16 >FY15 May-17 Unknown Unknown Unknown Unknown Unknown Unknown Remarks Settled along with 4 other players, Sun's case is still under litigation with Sanofi. Competition likely to be significant Teva tied up with Cipla here. Sun likely to enter post expiration of paeds exclusivity in Mar-12 Launch likely post Impax exclusivity. Impax has settled and exclusivity yet to begin. DRL, Mylan, Wockhardt other filers Generic entry is already there with approval of Dr Reddy's, Glenmark and Synthon's ANDA with sec viii for allergic rhinitis. Sandoz has also filed Sun enters post Wockhardt. Orion to supply generic versions. Mylan has also filed Likley to be a non-significant opportunity given multiple players Likley to be a non-significant opportunity given multiple players Lupin, Teva, Glenmark, Orchid have settled, others may settle as well. Peads exclusivity may push opportunity to May-14 Perrigo, Nycomed, Glenmark and Taro are settled for 15 Dec 2013 launch Teva had settled with Kos (under Abbott). Will launch on 20th Sep 2013. Sandoz, Zydus, Mylan and Lupin are other filers Teva launches in Aug-13 during paediatrics exclusivity. Sun can enter post that. Accord has filed too Teva launched its generic under name "Gianvi", breaking the terms of initial settlement for July-11 launch. Sandoz too has launched. Watson, Lupin, Mylan are other filers New formulation blocks generic approval till Dec-11. Anchen is other known filer Likley to be a non-significant opportunity given multiple players Teva is FTF with 505b(2) Teva lost in district court on '122 patent which expires in Dec 2013. Sun converted its P III to P IV in Dec-10. Mylan and Apotex have also filed 528 patent upheld by district court, generics lost exclusivity due to no tentative approval in 30mths. Many filers Teva to re-enter market in Dec-2015. Watson, Sandoz, Mylan and Lupin are other filers 314 patent paed expiry is Jan-16. Patent upheld in district court trial Sun has settled with launch dates not known. Teva is in the market Lilly recently won the appeals decision, patent upheld, launch post peads excl expiry in 2017 Sun has filed P-III on key patent which expires in Mar-12. Sun has obtained final approval on Nov-11 Caraco filing, outcome favorable for generics, timing uncertain due to Caraco issues. Site transfer likely. Approval still pending. Mylan Paddock, Sandoz are other filers Apotex, Sandoz are other filers Case schedule for trial in Oct-12 Mylan, DRL and Teva are other filers Mylan and Hospira are other known filers. Base patent expires in Feb-12 but Teva settled for Jun-19 launch. Teva has no tentative approval yet though

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

Escitalopram Oxalate Lexapro Fexofenadine + Pseudoephedrine Allegra D12 Levocetirizine Entacapone Duloxetine Dexmedetomidine Pregabalin Eszopiclone fluocinonide Niacin ER Xyzal Comtan Cymbalta Precedex Lyrica Lunesta Vanos Niaspan

Temozolomide Temodar Drospirenone + Ethinyl estradiol Yaz Tramadol extended release Memantine Esomeprazole Risedronate Aripiprazole Imatinib Estradiol, norgestimate Rosuvastatin Dexmethylphenidate Atomoxetine Tiagabine Repaglinide Pantoprazole Metformin ER Naproxen + sumatriptan Bivalirudin Total
Source: Company data, HSBC

Ryzolt Namenda Nexium IV Actonel Abilify

Schizophrenia, Bipolar Disorder, Depression Gleevec Chronic Myeloid Leukemia OrthoTricyclen Lo Oral Contraceptive Crestor High Cholesterol Focalin ADHD Strattera ADHD Gabitril Anti-Convulsant Prandin Type-2 Diabetes Protonix IV Glumetza Treximet Angiomax GERD Diabetes Migraine Anticoagulant

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Cadila: Key Generics Expected Timeline Molecule Desloratadine Pioglitazone Lansoprazole Calcium Acetate Duloxetine Niacin ER Aripiprazole Brand Indication Sales (USD mn) Who is FTF? 3,000 3,000 500 15 2,500 1,000 3,350 50 5 500 80 250 30 70 500 250 200 70 590 15,960 Multiple Multiple Teva Roxane Multiple Teva None Timeline 2012 Feb-13 May-13 Jun-13 Dec-13 Feb-14 After 2015 Remarks Zydus likely FTF on Clarinex Reditabs Zydus has settled the case. Will enter post FTF players in a crowded market Teva launched post approval on Oct 15, 2010. ODT patent expires in May 2013. Mylan is other filer Nabi Biopharma sued Roxane. Nabi sold the brand to Fresenius. Roxane has settled the case. Paddock and Lupin are known filers as well Cadila has tentative approval along with Impax, Sun, Torrent, Sandoz and Aurobindo. Will launch post FTF entry in June 2013 Teva had settled with Kos (under Abbott). Will launch on 20th Sep 2013. Sandoz, Sun, Mylan and Lupin are other filers Exclusivity lost likely for all generics

Generic Launch Calendar V India Pharmaceuticals 27 June 2012

Clarinex Asthma/Allergic Rhinitis Actos Diabetes Prevacid SoluTab/ODT Peptic Ulcer/Gerd Phos Lo Cymbalta Niaspan Abilify End stage renal disease Depression, Gad High Cholesterol Schizophrenia, Bipolar Disorder, Depression GERD Pain ADHD ADHD Allergic Rhinitis Sleep Disorder Attention deficit disorder (ADD) and narcolepsy ADHD Epilepsy Ulcerative Colitis Ulcerative Colitis MDD Depression

Omeprazole+sodium bicarbonate Zegerid Gabapentin ER Gralise Atomoxetine Strattera Methylphenidate HCl ER Capsules Azelastine Doxepin Methylphenidate HCl ER Capsules Dexmethylphenidate HCl ER Capsules Levetiracetam ER Tablets Mesalamine Mesalamine Desvenlafaxine succinate Total
Source: Company data, HSBC

Multiple Multiple Cadila Apotex Actavis, Par Actavis Generic

Metadate CD Astelin Selinor Ritalin LA Focalin XR Keppra XR Lialda Asacol HD Pristiq

After July 2016 four patents expire on July 2016. Cadila has also filed OTC Zegerid Sep-16 Earliest patent expiry in Sep-16, other players include Impax, Watson, Par, Incepta, May-17 Lilly recently won appeals case. Patent upheld. Zydus had settled with Lilly in 2007 and is arguing launch owing to earlier settlement Oct-20 Single patent expiry in Oct-20, only known filer, acquired from Nesher acquisition Unknown Unknown Unknown Unknown Apotex is in the market, Sun is also sued (and is present in azelastine drops) Mylan another filer. Brand was recently approved in 2010 Acquired from Nesher. Teva is known filer. Settled Acquired from Nesher. Mylan, Teva, Sun, Par and Actavis are other filers. Settled

Unknown Cadila Unknown Cadila Unknown Watson, Lupin, Zydus Unknown

Trial set for Oct 2012, patent expires in 2020 Strong filing, FTF likely Single patent expiring in 2022. 30 month block till April 2015 for all first filers. We expect more competition to emerge slowly by time of launch

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Generic Launch Calendar V India Pharmaceuticals 27 June 2012

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Disclosure appendix
Analyst Certification
The following analyst(s), economist(s), and/or strategist(s) who is(are) primarily responsible for this report, certifies(y) that the opinion(s) on the subject security(ies) or issuer(s) and/or any other views or forecasts expressed herein accurately reflect their personal view(s) and that no part of their compensation was, is or will be directly or indirectly related to the specific recommendation(s) or views contained in this research report: Girish Bakhru

Important disclosures
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Rating definitions for long-term investment opportunities


Stock ratings

HSBC assigns ratings to its stocks in this sector on the following basis: For each stock we set a required rate of return calculated from the cost of equity for that stocks domestic or, as appropriate, regional market established by our strategy team. The price target for a stock represents the value the analyst expects the stock to reach over our performance horizon. The performance horizon is 12 months. For a stock to be classified as Overweight, the potential return, which equals the percentage difference between the current share price and the target price, including the forecast dividend yield when indicated, must exceed the required return by at least 5 percentage points over the next 12 months (or 10 percentage points for a stock classified as Volatile*). For a stock to be classified as Underweight, the stock must be expected to underperform its required return by at least 5 percentage points over the next 12 months (or 10 percentage points for a stock classified as Volatile*). Stocks between these bands are classified as Neutral. Our ratings are re-calibrated against these bands at the time of any 'material change' (initiation of coverage, change of volatility status or change in price target). Notwithstanding this, and although ratings are subject to ongoing management review, expected returns will be permitted to move outside the bands as a result of normal share price fluctuations without necessarily triggering a rating change.

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*A stock will be classified as volatile if its historical volatility has exceeded 40%, if the stock has been listed for less than 12 months (unless it is in an industry or sector where volatility is low) or if the analyst expects significant volatility. However, stocks which we do not consider volatile may in fact also behave in such a way. Historical volatility is defined as the past month's average of the daily 365-day moving average volatilities. In order to avoid misleadingly frequent changes in rating, however, volatility has to move 2.5 percentage points past the 40% benchmark in either direction for a stock's status to change.

Rating distribution for long-term investment opportunities


As of 27 June 2012, the distribution of all ratings published is as follows: Overweight (Buy) 50% (26% of these provided with Investment Banking Services) Neutral (Hold) Underweight (Sell) 37% 13% (25% of these provided with Investment Banking Services) (16% of these provided with Investment Banking Services)

Information regarding company share price performance and history of HSBC ratings and price targets in respect of its longterm investment opportunities for the companies the subject of this report,is available from www.hsbcnet.com/research.

HSBC & Analyst disclosures


Disclosure checklist Company BIOCON LIMITED CIPLA DR. REDDY'S LAB. RANBAXY
Source: HSBC

Ticker BION.BO CIPL.BO REDY.BO RANB.BO

Recent price 231.05 308.00 1600.90 486.95

Price Date 26-Jun-2012 26-Jun-2012 26-Jun-2012 26-Jun-2012

Disclosure 2,5,6,7 2,6,7 4 2,6,7

1 2 3 4 5 6 7 8 9 10 11

HSBC* has managed or co-managed a public offering of securities for this company within the past 12 months. HSBC expects to receive or intends to seek compensation for investment banking services from this company in the next 3 months. At the time of publication of this report, HSBC Securities (USA) Inc. is a Market Maker in securities issued by this company. As of 31 May 2012 HSBC beneficially owned 1% or more of a class of common equity securities of this company. As of 30 April 2012, this company was a client of HSBC or had during the preceding 12 month period been a client of and/or paid compensation to HSBC in respect of investment banking services. As of 30 April 2012, this company was a client of HSBC or had during the preceding 12 month period been a client of and/or paid compensation to HSBC in respect of non-investment banking-securities related services. As of 30 April 2012, this company was a client of HSBC or had during the preceding 12 month period been a client of and/or paid compensation to HSBC in respect of non-securities services. A covering analyst/s has received compensation from this company in the past 12 months. A covering analyst/s or a member of his/her household has a financial interest in the securities of this company, as detailed below. A covering analyst/s or a member of his/her household is an officer, director or supervisory board member of this company, as detailed below. At the time of publication of this report, HSBC is a non-US Market Maker in securities issued by this company and/or in securities in respect of this company

Analysts, economists, and strategists are paid in part by reference to the profitability of HSBC which includes investment banking revenues. For disclosures in respect of any company mentioned in this report, please see the most recently published report on that company available at www.hsbcnet.com/research. * HSBC Legal Entities are listed in the Disclaimer below.

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Additional disclosures
1 2 3 This report is dated as at 27 June 2012. All market data included in this report are dated as at close 26 June 2012, unless otherwise indicated in the report. HSBC has procedures in place to identify and manage any potential conflicts of interest that arise in connection with its Research business. HSBC's analysts and its other staff who are involved in the preparation and dissemination of Research operate and have a management reporting line independent of HSBC's Investment Banking business. Information Barrier procedures are in place between the Investment Banking and Research businesses to ensure that any confidential and/or price sensitive information is handled in an appropriate manner. As of 31 May 2012, HSBC and/or its affiliates (including the funds, portfolios and investment clubs in securities managed by such entities) either, directly or indirectly, own or are involved in the acquisition, sale or intermediation of, 1% or more of the total capital of the subject companies securities in the market for the following Company(ies) :DR. REDDY'S LAB.

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Disclaimer
* Legal entities as at 12 June 2012 Issuer of report UAE HSBC Bank Middle East Limited, Dubai; HK The Hongkong and Shanghai Banking Corporation Limited, HSBC Securities and Capital Markets Hong Kong; TW HSBC Securities (Taiwan) Corporation Limited; 'CA' HSBC Bank Canada, Toronto; HSBC Bank, (India) Private Limited Paris Branch; HSBC France; DE HSBC Trinkaus & Burkhardt AG, Dsseldorf; 000 HSBC Bank (RR), Moscow; Registered Office IN HSBC Securities and Capital Markets (India) Private Limited, Mumbai; JP HSBC Securities (Japan) Limited, 52/60 Mahatma Gandhi Road Tokyo; EG HSBC Securities Egypt SAE, Cairo; CN HSBC Investment Bank Asia Limited, Beijing Representative Office; The Hongkong and Shanghai Banking Corporation Limited, Singapore Branch; The Hongkong and Fort, Mumbai 400 001, India Shanghai Banking Corporation Limited, Seoul Securities Branch; The Hongkong and Shanghai Banking Telephone: +91 22 2267 4921 Corporation Limited, Seoul Branch; HSBC Securities (South Africa) (Pty) Ltd, Johannesburg; GR HSBC Fax: +91 22 2263 1983 Securities SA, Athens; HSBC Bank plc, London, Madrid, Milan, Stockholm, Tel Aviv; US HSBC Securities (USA) Website: www.research.hsbc.com Inc, New York; HSBC Yatirim Menkul Degerler AS, Istanbul; HSBC Mxico, SA, Institucin de Banca Mltiple, Grupo Financiero HSBC; HSBC Bank Brasil SA Banco Mltiplo; HSBC Bank Australia Limited; HSBC Bank Argentina SA; HSBC Saudi Arabia Limited; The Hongkong and Shanghai Banking Corporation Limited, New Zealand Branch incorporated in Hong Kong SAR This document has been issued by HSBC Securities and Capital Markets (India) Private Limited ("HSBC") for the information of its customers only. 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