Menu

Generics/News

picture06

Sun gains tentative approval for generic Crestor

Generics/News | Posted 21/01/2011

Indian-based Sun Pharmaceutical Industries announced on 29 September 2010 that the FDA had granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceuticals’ (a part of AstraZeneca) anti-cholesterol drug Crestor (rosuvastatin calcium).

picture08

WHO prequalification programme for APIs

Generics/News | Posted 14/01/2011

The WHO initiated on 21 October 2010 a pilot prequalification programme for selected active pharmaceutical ingredients (APIs) used in drugs for HIV and related diseases, antimalaria and anti-tuberculosis medications.

picture31

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.

picture28

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.

picture49

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.

picture59

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.

picture53

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.

picture34

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).

picture40

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.

picture10

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.

picture28

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.

picture03

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.

picture47

An ageing population: generics and biosimilars could be the solution

Generics/News | Posted 19/11/2010

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.

picture11

FDA user fees for assessing generic drugs

Generics/News | Posted 12/11/2010

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…

picture31

Teva continues to expand

Generics/News | Posted 08/11/2010

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.

picture06

Teva challenged over 180-day marketing exclusivity

Generics/News | Posted 29/10/2010

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.

picture06

Big shifts in generics shares due to Dutch preference policy

Generics/News | Posted 30/03/2010

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.

picture54

Celgene and Natco in generic lenalidomide battle

Generics/News | Posted 24/09/2010

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.