Generics/News

FDA considering tighter controls on generics

Generics/News | Posted 07/01/2011

The FDA may tighten standards for how closely generic drugs resemble brand-name equivalents. This comes as a result of complaints from both patients and employees of generic drugmakers that some of the medicines do not work as well as the originals.

Generic combination antibiotic launched in US

Generics/News | Posted 07/01/2011

On 26 October 2010, Hospira announced the launch of its combination antibiotic (piperacillin and tazobactam) for injection in the US. The medication is a generic version of Zosyn, the world’s leading injectable antibiotic, from Pfizer (Wyeth). Piperacillin and tazobactam injection posted sales in the US in 2009 of more than US$855 million.

Tackling counterfeit drugs in China

Generics/News | Posted 17/12/2010

The Chinese State Council, or cabinet, said on 19 October 2010 it would “launch a special campaign to fight intellectual property rights infringement and the manufacture and sale of counterfeit goods” at a meeting chaired by Premier Wen Jiabao. The six-month campaign, which includes making sure government organisations use genuine software, will begin at the end of October 2010, said the State Council.

India’s top pharma company strengthens ties with South Africa

Generics/News | Posted 17/12/2010

Generics’ manufacturer Cipla is a prominent Indian pharmaceutical company, best known outside its home country for manufacturing low-cost anti-AIDS drugs for HIV-positive patients in developing countries. Cipla exports to 170 countries and its manufacturing facilities are approved by WHO, US FDA, UK MHRA and other major agencies. Cipla was responsible for lowering the cost of triple therapy antiretroviral (ARV) to less than US$1 per day and is, in partnership with the Clinton Foundation, to supply ARVs to third world countries.

A view from South Africa

Generics/News | Posted 17/12/2010

Aspen Pharmacare, Africa’s biggest generic drugs company, reported a 24% rise in full-year profit at the end of June 2010, boosted by its South African unit, and says it expects strong demand in the coming year.

Apotex loses fight over Plavix patents

Generics/News | Posted 10/12/2010

Apotex was told to pay sanofi-aventis (sanofi) and Bristol-Meyers Squibb (BMS) a whopping US$442 million (plus interest) for violating patents on the blockbuster blood-thinner Plavix (clopidogrel bisulphate).

FDA grants approval for generic lansoprazole

Generics/News | Posted 03/12/2010

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

Generics/News | Posted 03/12/2010

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

Generics/News | Posted 26/11/2010

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!

Generics/News | Posted 19/11/2010

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.