Generics

US and EU get tough on 'pay-for-delay’ deals

Generics/News | Posted 30/09/2009

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.

Brand-name drugs are not more effective than generic versions for treating cardiovascular disease

Generics/Research | Posted 14/09/2009

A recent review in Evidence-Based Medicine by Dr Braden Manns of the University of Calgary in Canada studies the question whether generic drugs are as effective as brand-name drugs for treating cardiovascular disease.

Generic drug companies adapt to survive

Generics/News | Posted 14/09/2009

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

Generics/News | Posted 11/09/2009

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.

EvaluatePharma: Generic players impress in the first half

Generics/News | Posted 11/09/2009

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:

FTC and Teva disagree on 'pay-for-delay' deals savings

Generics/News | Posted 04/09/2009

In a speech on 23 June 2009 before the Center for American Progress in Washington, DC, USA, Federal Trade Commission (FTC) Chairman Jon Leibowitz said that an internal FTC analysis projects that stopping collusive ‘pay-for-delay’ settlements between brand and generic pharmaceutical firms would save consumers US$3.5 billion (Euros 2.5 billion) a year and also reap significant savings for the federal government, which pays approximately one-third of all prescription drug costs. Mr Leibowitz urged Congress to pass pending legislation to ban or restrict such anticompetitive patent settlements, in which manufacturers of brand-name drugs pay potential generic competitors to stay out of the market, as a way to control prescription drug costs, restore the benefits of generic competition, and help pay for healthcare reform.

Teva looking for ‘major’ acquisition

Generics/News | Posted 31/08/2009

Just a year after swallowing the US$7.4 billion (Euros 5.3 billion) Barr Laboratories buy, Teva Pharmaceutical Industries is ready for another ‘major’ acquisition and may look beyond generic drugs for the purchase, CEO, Mr Shlomo Yanai, said. According to him, Teva is seeking targets to diversify in branded medicines as well as increase its market share in generic drugs. “If we find a target that is in line with our strategy in the specialty area, in the biotechnology area, we definitely are going to consider it,” Mr Yanai said. “We are not limiting ourselves to buying only generic companies.” He declined to name possible targets.

Watson to acquire Arrow to double generics business

Generics/News | Posted 31/08/2009

Watson Pharmaceuticals announced it has entered into a definitive agreement to acquire privately held Arrow Group for US$1.75 billion (Euros 1.25 billion) in cash and stock. The combination of Watson and Arrow will result in a global pharmaceutical company with over US$3 billion (Euros 2.15 billion) in revenue, commercial operations in over 20 countries, and a robust product portfolio and pipeline. Watson expects the transaction to close in the second half of 2009, and be accretive to cash earnings per share in 2010 before synergies.

Pfizer plans partnerships and acquisitions in generics

Generics/News | Posted 31/08/2009

Pfizer, the world's biggest drugmaker, is seeking deals with generic pharmaceutical manufacturers to increase sales of medicines that have lost patent protection.

International comparison of generic medicine prices

Generics/Research | Posted 29/07/2009

The introduction of generic price-regulated systems in many European countries, the trend towards international generic medicine companies, and competition from Indian companies emphasises the need to gain insight into international prices of generic medicines.