Generics/News
Teva again files citizen petition against generic Copaxone
Teva Pharmaceutical Industries announced on 12 December 2010 that the company had filed another Citizen’s Petition (CP) with the FDA requesting that the agency refuse to approve any abbreviated new drug application (ANDA) for generic versions of Copaxone (glatiramer acetate injection).
Teva setbacks
Teva axes 200 jobs as facility remains closed
After stopping all production at its plant in Irvine, California, USA; in April 2010, Teva announced on 20 January 2011 that all 200 jobs will go.
Race you for US$1.8 billion
The market for proton pump inhibitor pantoprazole in the US is estimated to be worth Euros 1.3 billion a year, and drug companies are scrambling to sell generic versions now that Pfizer’s patent has expired.
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.
