Ranbaxy Laboratories will start selling the generic version of Norvasc, a drug sold by Pfizer Inc and is used to treat hypertension and angina (a heart condition). The drug’s generic name is amlodipine besylate. Ranbaxy said that the Canadian market for amlodopine besylate is CAD $456mn or Rs 2014 crore (1CAD=Rs 44.2). Ranbaxy’s launch is thanks to the European pharmaceutical company, ratiopharm of Germany.
Pfizer’s original patent for Norvasc was to expire in Canada in 2010. But ratiopharm Canada (a subsidiary of ratiopharm, Germany) won an important court case on July 8, 2009, in Canada’s Federal Court, invalidating Pfizer’s patent on the drug. That decision will allow generic makers having approval to market the generic version of the drug, to enter the market immediately. Pfizer has said it plans to appeal against the decision to the Federal Court of Appeal of Canada. And, it also noted that litigation with other pharmaceutical companies was going on in Canada for the same drug.
ratiopharm was quick to launch its drug, after winning the case, under the name ratiopharm-Amlodipine for the 5mg and 10mg doses. Ranbaxy will sell its generic version under the Ran-Amlodipine name for the same doses. Ranbaxy will make the products at its Ohm Laboratories’ facility in New Jersey and said the product will be distributed to all classes of trade, and it expects to get formulary inclusion within weeks (essential for the drug to be prescribed by doctors). The company has not indicated a time frame within which it will do a commercial launch.
ratiopharm said that nearly 8mn prescriptions for Norvasc are issued annually in Canada to treat high blood pressure and angina. Amlodipine is the highest selling medicine in its class (calcium channel blockers) and the second highest selling medicine in Canada. The company claims that $180mn in savings could accrue to Canadian patients and the healthcare system due to the entry of generic drugs. Adjusting the market size mentioned earlier, we are looking at significant erosion in the market price. Generic players price their drugs at a discount to the innovator, to get patients or service providers to switch prescriptions. Even after the price erosion, the generic players will still make sizeable margins, as there are only two players as of now, apart from the innovator company. More companies could enter the market and the price erosion could be higher.
ratiopharm claims to be the first to challenge the amlodipine besylate patent in 2004 in Canada. While ratiopharm’s patent challenge succeeded in the Federal Court in Feb 2006, Pfizer won an appeal in the case. Then, the company went to court asking for an invalidation of Pfizer’s five patents under the Patent-Act. ratiopharm won the case, invalidating all five patents.
The development is good news for Ranbaxy which has been having a tough time in the US generic market, with the US FDA pulling it up for some of its facilities not meeting FDA’s norms.
Ranbaxy’s announcement to the BSE, ratiopharm’s press release on the subject and Pfizer’s statement on the court decision.