Sun Pharma

vs. Astra Zeneca

-Ruchit Darji
M.Pharm
• Sun Pharma had a patent dispute with MedImmune, a
unit of major Astra Zeneca.

• The litigation was in US district court.

• Dispute was posed on the patent rights of Ethyol

(Amifostine)
• Sun Pharma had got US Food and Drug Administration
(USFDA) approval for the drug in March 2008 and had
launched the product ‘at risk’ in the US market.

• This followed a marketing application to market a

generic version of amifostine for injection, challenging
the patent.
Advantage for Defendant

First-to-file an Abbreviated New Drug Application

(ANDA) for generic Ethyol with a Para IV certified
patent challenge, has a 180-day marketing exclusivity
in the US market
Verdict

Under the agreement, MedImmune has granted Sun

Pharma a license to certain patents, permitting Sun
Pharma to continue marketing its generic version of
Ethyol in the US.
Present Situation
Sun Pharma’s product is being sold in the US by
its marketing partner, Caraco Pharmaceutical
Laboratories.

Ethyol has annual sales of approximately $80

million in the US
THANK YOU…