Plavix Goes Generic in US
The US FDA yesterday (17 May) approved generic versions of clopidogrel, the active ingredient of Sanofi (France)'s cardiac blockbuster Plavix; in the absence of a six-month exclusivity, several generics manufacturers are already lined up to decimate the branded franchise.
IHS Global Insight Perspective
The approval follows on from the generic entry of Pfizer's Lipitor (atorvastatin) at the tail-end of 2011, as the two best-selling drugs over the last decade or so fall off the branded radar and become replaced with generic versions. Consequently, the overall volume of atorvastatin and clopidogrel will probably increase alongside the increased affordability of these drugs.
Unusually, since Apotex (Canada) has relinquished its six-month exclusivity rights after briefly entering the generic clopidogrel market in 2006, companies such as Mylan (US), Dr. Reddy's (India), Teva (Israel), Gate Pharmaceuticals (US), Apotex, Aurobindo (India), Roxane (US/Germany), Sun Pharma (India) and Torrent Pharmaceuticals (India) are all immediately lined up to enter the generic Plavix market.
The European market has already seen generic clopidogrel since the second half of 2008 as a result of a weaker composition patent in Europe, and the European precedent saw a relatively fast decimation in sales for the branded version. It will also put more pressure on new therapies in this market, such as Eli Lilly (US)'s Effient (prasugrel) and AstraZeneca (UK)'s Brilinta (ticagrelor), with more emphasis on their clinical differentiation in order to prove their cost-benefit.
The United States' FDA yesterday (17 May) announced that it has approved generic versions of Sanofi (France) and Bristol-Myers Squibb's (BMS, US) best-selling blood thinner Plavix (clopidogrel bisulphate). Before its patent expiration in Europe, Plavix reached peak sales of around USD9 billion, the second-biggest selling drug behind the recently genericised Lipitor (Pfizer, US). Clopidogrel is used in patients who have recently had a heart attack or stroke, or have a partial or total blockage of an artery through peripheral artery disease. The FDA's announcement is available here.
The announcement falls in-line with expectations, and several generics firms have immediately made clear that generic clopidogrel launches are imminent.
- The FDA has confirmed that the 300-mg version will be targeted by Dr. Reddy's (India), Gate Pharmaceuticals (US), Mylan (US) and Teva (Israel).
- The 75-mg version will be targeted by Apotex (Canada), Aurobino (India), Mylan (US), Roxane (US/Germany), Sun Pharma (India), Teva and Torrent Pharmaceuticals (India).
Apotex had originally been positioned as the first generic company to enter the generic Plavix market, launching its 75-mg version in 2006. However, following the loss of its court case over the unauthorised generic, Apotex has forfeited its right to the six-month exclusivity against the 75-mg version. This means that the patent expiration of Plavix 75 mg is marked by the relatively unusual situation where a generic free-for-all will immediately follow. This will mean that sales will be decimated in an even steeper fashion than with normal patent expirations, where the six-month exclusivity, while providing strong incentives for generics firms to position themselves as the first generic competitor to any franchise, reduces the initial price erosion and competitiveness of the market. Mylan, meanwhile, has positioned itself as the first-to-file for the 300-mg version, and maintains its six-month exclusivity period until November; it has confirmed that it has already commenced shipping both doses, which puts it at a strong competitive advantage vis-à-vis the other generics.
Outlook and Implications
The European market has already seen generic clopidogrel since the second half of 2008 as a result of a weaker composition patent in Europe, and the European precedent saw a relatively fast decimation in sales for the branded version. BMS and Sanofi, meanwhile, are offering discounts and coupons to patients who continue using branded Plavix. The coupons seek to pre-empt switches to generics by reducing the overall cost from around USD175 per month to less than USD40 per month. Still, generic entry here will also put more pressure on new therapies in this market, such as Lilly's Effient (prasugrel) and AstraZeneca's Brilinta (ticagrelor), with more emphasis on their clinical differentiation in order to prove their cost-benefit.
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