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FDA grants approval for generic lansoprazole

Teva Pharmaceutical Industries announced on 18 October 2010 that it had received FDA approval for its Abbreviated New Drug Application for its generic version of Takeda's Prevacid (lansoprazole) SoluTab.

Teva brings another action against Mylan

In October 2009, Teva Pharmaceutical Industries filed a lawsuit against Mylan for infringement of multiple patents, with respect to patents on its glatiramer acetate drug–Copaxone. The patents cover pharmaceutical compositions containing it, methods of using it and processes for making it. Those patents expire in May 2014 and September 2015. No trial date is scheduled.

Ranbaxy beats Teva to Alzheimer’s drug

Aricept (donepezil hydrochloride), Eisai Pharmaceutical’s biggest selling drug, comes off patent in the US in November 2010. Thereafter donepezil hydrochloride may be sold as a generic drug. Teva has applied to sell donepezil, but the FDA granted Ranbaxy first access to the lucrative market in a letter dated 17 September 2010.

Go Perrigo!

Generic drug maker Perrigo has made it to Fortune magazine's top 100 fastest growing companies in the US. Fortune is a business magazine especially known for ranking companies by revenue. So there is some rejoicing in Michigan as the local hero has now received national acclaim.

An ageing population: generics and biosimilars could be the solution

On 17 October 2010 the European Generic Medicines Association (EGA) organised an event to discuss patient access to affordable treatments and healthcare sustainability in view of an increasingly ageing population.

FDA user fees for assessing generic drugs

The FDA is beginning a long-awaited attempt to create a system of user fees for assessing generic drugs. The US agency has a backlog of more than 2,000 products to review and has been short of funds for years. But things are never straightforward…

Teva continues to expand

The world's largest generic pharmaceutical company, Israeli-based Teva Pharmaceutical Industries, is investing Euros 42 million to expand its production plant in Stouffville, Canada. At the same time Ontario is providing a Euros 4.8-million grant to Teva Canada, which will retain 182 high-skilled workers and hire 20 new employees.

Teva challenged over 180-day marketing exclusivity

Canadian generics’ manufacturer Apotex has asked the US Supreme Court to hear a case that could have a lasting impact on how marketing exclusivity is awarded to generic-drug manufacturers by the FDA.

Big shifts in generics shares due to Dutch preference policy

The percentage of generic prescribing in The Netherlands increased in 2009 from 56.3– 57.1% according to the Dutch Stichting Farmaceutische Kengetallen (SFK), as published in Pharmaceutisch Weekblad of 12 March 2010.

Celgene and Natco in generic lenalidomide battle

Indian generics’ manufacturer Natco Pharma (Natco) has filed an abbreviated new drug application (ANDA) with the FDA seeking approval to sell a generic version of Celgene Corporation’s (Celgene’s) flagship blood cancer drug Revlimid (lenalidomide), before its patent protection expires.

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