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Sun Pharma In The News

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Sun settles Plavix patent dispute with Sanofi, BMS


SUN Pharmaceutical In­dustries, India's largest drugmaker by market val­ue, has settled its patent case with New York-head­quartered Bristol-Myers Squibb (BMS) and Paris-headquartered Sanofi over Plavix, a drug used to in­hibit blood clots in coro­nary artery disease.
Last week in the South­ern New York district court, Sun Pharmaceutical Industries and the two global drugmakers signed on the settlement that takes care of all issues over US patent no. 6,429,210.
This patent, issued in August 2002, covers an active ingredient of Plavix called clopidogrel bisulfate and expires on May 17, 2012 — less than 6 months away. Sun was first sued in July 2008 over generic Plavix.
Plavix is second-best selling drug in the world with $6billion in US annual sales. Cholesterol lower­ing Lipitor is the best-selling drug in the world with projected $10.7 billion in sales for 2011.
Plavix was discovered by Sanofi-Aventis and was co-developed with Bristol-Myers Squibb. Sanofi con­firmed the deal. Marisol Person, senior director, corporate media relations of Sanofi said: "We can confirm the settlement. At this point we are not commenting further."
As per the settlement, Sun Pharmaceutical Industries has been stopped from making or selling its proposed generic except as permissible under the parties' deal. Sun has entered into a licence agreement with Sanofi-BMS. This could be in form of an authorised generic that Sun could make in case of Plavix as other generic drugmakers are also ex­pected to enter the market from day one.
Simply put, authorised generics are prescription drugs produced by entities  licenced by brand pharmaceutical companies and marketed under a private label at generic prices.
When asked, a Sun spokesperson said: "We would not be able to re­spond to these queries ow­ing to confidentiality pro­visions."
An authorised generic settlement could be one of the ways Sanofi-BMS may want to control prices of Plavix as introduction of generics lead to price drops of 70-80 per cent mostly within 6 months. US drug company Apotex did launch its version of generic Plavix in 2006 for which it recently paid $551 million penalty and appears to have lost the 180-day exclusivity.
In July 2011, Sun got a tentative approval for its Abbreviated New Drug Application (ANDA) for generic version of Plavix. Much earlier in January 2008, Dr Reddy's Labora­tories had won US regula­tory approval to sell its ver­sion of Plavix.