Generics/News
FDA approval for generic diabetes drug Actos
On 17 August 2012, FDA gave final approval to Mylan Pharmaceuticals for the first generic version of Actos (pioglitazone hydrochloride tablets), for the treatment of type 2 diabetes. The approval covers tablets containing 15 mg, 30 mg and 45 mg pioglitazone.
Court upholds decision against AstraZeneca’s omeprazole
On 1 July 2010, the General Court of the European Union (GCEU) upheld the decision of the European Commission (EC), which found that AstraZeneca had abused its dominant position by preventing the marketing of generic versions of Losec (omeprazole).
Gilead makes HIV generics deal
US-based drugmaker Gilead Sciences (Gilead) announced on 2 August 2012 a new collaboration with Indian generics manufacturers to provide low cost HIV medicine to developing countries.
Ranbaxy forfeits exclusivity on generic Provigil
As part of Ranbaxy’s consent decree with FDA, signed in January 2012, the Indian generics major had to agree to relinquish 180-day marketing exclusivity on three pending generic drug applications [1]. Now analysts believe that generic Provigil (modafinil) may have been one of those undisclosed drugs.
FDA approves generics of Merck’s Singulair
FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).
Pfizer wins against generic versions of pain drug Lyrica
The world’s largest drugmaker Pfizer has successfully blocked Israel-based Teva Pharmaceutical Industries (Teva) and other manufacturers from selling generic versions of its fibromyalgia treatment Lyrica (pregabalin) until patents on the drug expire in 2018. The ruling, announced on 19 July 2012, was the result of a lawsuit begun in 2009 contending that sales of generic Lyrica would infringe Pfizer’s patents and cause irreparable harm to sales.
Watson gains FDA approval for morning after pill
US generics company Watson Pharmaceuticals (Watson) announced on 13 July 2012 that its subsidiary Watson Laboratories, has received approval from FDA for its Abbreviated New Drug Application (ANDA) for Next Choice One Dose (levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women’s Health’s Plan B One-Step. Watson plans to launch the product immediately.
More downs than ups for Ranbaxy
A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the Maharashtra FDA (FDA, Maharashtra State, India). The Indian crack-down on Ranbaxy follows in the wake of a consent decree issued by US FDA in January 2012 which tightens scrutiny of Ranbaxy’s quality control and reporting measures.
Apotex gains reprieve after Merck loses ruling―but for how long
Toronto-based pharmaceutical firm Apotex has won a stay of execution for its nasal spray generic product after a US District Court in New Jersey, USA, turned down a patent infringement claim by Merck & Co’s Schering-Plough unit.
Generic Adderall XR approved in the US
Shire announced on 23 June 2012 that it had lost its battle to protect its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts). FDA approved the abbreviated new drug application (ANDA) from Actavis, a unit of US generics company Watson Pharmaceuticals, for the ADHD drug on 22 June 2012.
