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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.

FDA rejects pseudoephedrine application due to deficiencies

On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-release pseudoephedrine.

Indian generics companies to strengthen in 2011

Dispute with EU resolved

The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.

New ANDAs and patent challenges for Impax Laboratories

Impax Laboratories is facing a whole barrage of patent litigation following its latest Abbreviated New Drug Application (ANDA) filings and approvals with the FDA.

Germany tightens controls on pharmaceutical prices

The German government is contemplating pharmaceutical price control legislation as it battles soaring drug spending. On the one hand Germany is keen to promote the use of generic drugs and generic medicines have already achieved high penetration—75% by volume in 2009. This highlights opportunities for generic manufacturers in Europe's largest, albeit competitive, drug market.

India under attack

India is coming under attack from Big Pharma from all angles it seems. On the one hand the Indian Government has alleged that multinational companies are campaigning against the country’s domestic pharmaceutical industry due to India’s increasing generic global presence. Then on the other hand Novartis has been asked to end its challenge to Indian patent law, with claims that its action could hinder global access to medicine.

Sun Pharma continues to expand its generics portfolio

Sun Pharma is keeping up the momentum in the generics market with several new generics recently gaining FDA approval and with an extensive pipeline on the way. The latest generics to come out of the company include drugs for the treatment of hypertension, allergic rhinitis and depression.