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Ranbaxy may sell its generic atorvastatin exclusivity

According to Credit Suisse analysts, Ranbaxy Laboratories (Ranbaxy) may sell its rights to make a generic version of Pfizer’s cholesterol blockbuster Lipitor (atorvastatin), should it look unlikely to gain FDA approval in time for the planned November 2011 launch.

Generics manufacturers do not have to change drug safety labels in the US

A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warnings are found to be required [1- 2]. This is the opposite of a ruling in 2009 that decided that patients could sue the manufacturer of a brand-name drug if its safety label is found to be inadequate, e.g. when new drug-related risks are discovered after the drug has made it to market [3, 4].

Domestic Indian market spawns generic agreements

India’s population is growing rapidly—as is its economy—creating a large middle class with the resources to afford western medicines. This fact has seen a spate of western companies stepping forward to make agreements with Indian generics manufacturers in order to get a foothold in this developing market.

GPs in the UK to be banned from prescribing branded statins

General Practitioners (GPs) in Cambridgeshire, UK, have been told by the national health service (NHS) that they are considering proposals to ban prescribing of branded statins in favour of cheaper generic alternatives according to a report in Pulse.

UK Government sues Servier for generic blocking

The UK’s Health Secretary, Mr Andrew Lansley, has issued a GBP 220 million (Euros 246 million; US$360 million) lawsuit against French drug company Servier for allegedly ‘abusing’ its dominant position and delaying rivals from launching generic versions of its angiotensin-converting enzyme inhibitor, perindopril (Coversyl).

US drug shortages – FDA may hinder, but APP may help

Drug shortages are at a record high, and some blame the policies of the FDA for causing some of these. However, good news is on the horizon as US drugmaker APP Pharmaceuticals has decided to boost its manufacturing capacity for injectable generic drugs. This could help to fight against the growing list of drug shortages reported by the FDA.

Generics will not have to change their labelling

The US Supreme Court has decided that generics makers cannot be sued under state law for not changing their labels to warn of possible side effects. That is a big victory for Actavis, Mylan and Teva, which had faced appeals against court rulings that would have allowed them to be sued under state law.

Ranbaxy launches generic olanzapine in Spain

Eli Lilly may be facing pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 25 April 2011,the first day after Eli Lilly’s patent exclusivity expired in Spain, Ranbaxy Laboratories announced that it had launched its generic version of the treatment.

Generic prices in Australia slashed

In response to an article by Professor Philip Clarke in the Australian Financial Review titled Time to slash cost of generics, Medicines Australia Chief Executive Dr Brendan Shaw hit back saying that ‘the price of generic medicines on the Pharmaceutical Benefits Scheme (PBS) is already being reduced by as much as 70%.’

Branded generics and generics branding for Merck and sanofi-aventis

While Merck is getting a firm foothold in emerging markets with a branded generics deal with India-based Sun Pharma, sanofi-aventis has decided to unify its generics business under the brand name Zentiva.