Generics/News
EU to seek details of drugmakers' patent deals
EU regulators will ask drug companies for details of deals with makers of generic medicines as part of a crackdown on firms suspected of blocking cheaper treatments, a European Commission (EC) official said on 19 November 2009.
Growing generic injectables market: a cousin to biosimilars
Drugmakers are waking up to the opportunities in the generic injectables market for several reasons, not least of which are the high-profit margins the products can deliver. The segment also involves fast-growing therapeutic areas like oncology, anti-infectives and central nervous system (CNS) disorders. And for companies with an eye on the long-term prize, commercial and manufacturing experience in specialty generics could pave the way for a smoother entry into the biosimilars market when a regulatory pathway for low-cost biologics is created in the US.
Generics drive Dr Reddy's Q2 revenues up 14%
On 23 October 2009, Dr Reddy's Laboratories in India reported a 14% increase in consolidated revenues to Rs18.4 billion (Euros 263.94 million) for the second quarter that ended on 30 September 2009, driven by growth in the generics business.
Actavis launches generic challenge to Pfizer’s Lipitor
On 1 October 2009, Actavis, the Iceland-based generic company, launched the most high-profile commercial challenge in Western Europe to Pfizer’s best-selling and patent-protected medicine.
FDA approves generic prescription-only version of Plan B emergency contraceptive levonorgestrel for women ages 17 and under
The US FDA on 24 June 2009 approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.
Many potential buyers as sale of Ratiopharm begins
The process of divesting Ratiopharm, the world's fourth-largest generic drugmaker, owned by the conglomerate formerly run by German billionaire Mr Adolf Merckle who committed suicide at the start of the 2009 is underway.
US and EU get tough on 'pay-for-delay’ deals
Forces are aligning against ‘pay-for-delay’ patent deals, reported FiercePharma. After years of expressing contempt for the US Federal Trade Commission's (FTC) fight against the deals, the US Department of Justice (DOJ) has now signed up to the cause. In an appellate court filing, the DOJ said that it is unlawful for branded drugmakers to pay generic firms to stand down from patent challenges – unless the drugmakers can justify the deal.
EvaluatePharma: Generic players impress in the first half
Which pharma firm is the most profitable? A new analysis of net margins by EvaluatePharma tagged companies for profitability, and the winner was not one of the big pharma companies, e.g. Johnson & Johnson or Pfizer, but PDL BioPharma:
Generic drug companies adapt to survive
The prospects seem bright for generics companies. Healthcare systems are increasingly looking for ways to cut costs, and patents are expiring on a growing number of medicines produced by innovative pharmaceutical companies. Yet recent forces have intensified not only the traditional tensions between the generic producers and their innovative rivals, but also among the generic companies themselves. Therefore the mood of many of the delegates at the European Generic medicines Association annual meeting recently held in Barcelona, Spain, was gloomy, as reported by Mr Andrew Jack in the Financial Times.
Conflicting interpretations of data exclusivity and non-authorised medicinal products
The European Court of Justice (ECJ) has handed Shire Plc and Janssen-Cilag Ltd, a Johnson & Johnson (J&J) company, a victory against Generics [UK] Ltd in a case involving the Alzheimer's treatment Reminyl. The court's ruling is in line with the rejection of Generics UK’s marketing authorisation for a form of galantamine by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA decision was based in part on an attempt by the generic-drug maker to reference a drug approved in Austria in 1963. The marketing authorisation for Nivalin (galantamine), the drug Generics UK referenced, was not updated after Austria joined the EU to comply with European Community law and cannot be used as a reference product. Nivalin was sold by Waldheim Pharmazeutika, which had approval to market the drug as a treatment for polio until 2001. Janssen-Cilag entered into an agreement with Waldheim to gain marketing authorisation for galantamine in 2000, to be sold under the brand Reminyl for Alzheimer's disease.
