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Generics to cash in on swine flu epidemic

Indian drug manufacturer Natco Pharma has filed an abbreviated new drug application (ANDA) with the FDA for a generic version of Tamiflu (oseltamivir), challenging Gilead Science’s patent protection on the drug.

Impax challenges Simcor patent

On 26 November 2010, generic drug maker Impax Laboratories announced that it is challenging the patent covering Abbott Laboratories’ cholesterol-treatment drug, Simcor (niacin/simvastatin).

Pharmacy chains in Norway do not stock generics

It turns out that pharmacy chains in Norway do not stock the cheapest generic products. This finding came after the Norwegian Medicines Agency (NoMA) investigated after receiving a complaint from the British generics manufacturer Arrow that its products were not sold in branches of the three largest pharmacy chains in Norway: Apotek1 (Phoenix), Vitusapotek (Celesio) and Alliance/Boots Apotek (Alliance Boots).

Profits for generics’ giant Teva soar

Israel-based generics’ giant Teva Pharmaceutical Industries has reported a third quarter 2010 profit rise of 47%, mainly attributed to sales of its multiple sclerosis drug Copaxone (glatiramer acetate), its acquisition of Ratiopharm and generic launches in the US.

Ranbaxy gets 180-day exclusivity for Alzheimer’s generic

On 30 November 2010, generics’ giant and India’s largest pharmaceutical manufacturer, Ranbaxy Laboratories, announced the launch of a generic version of Pfizer’s blockbuster Alzheimer’s treatment, Aricept (donepezil hydrochloride), in the US.

Sun gains tentative approval for generic Crestor

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).

WHO prequalification programme for APIs

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.

FDA considering tighter controls on generics

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

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

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.