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Generics/News

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Biovail says Teva’s generic bupropion trial is too small

Generics/News | Posted 19/02/2010

As reported by Reuters, Biovail, Canada's biggest publicly traded pharmaceutical company said on 22 January 2010 that it believes a proposed clinical trial by Teva of a generic version of Biovail's sustained-release Wellbutrin XL (bupropion) antidepressant drug is too small and brief to be effective.

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India urges WHO to ‘clearly promote’ generics

Generics/News | Posted 18/02/2010

As reported by Scrip on 25 January 2010, India has urged the World Health Organization (WHO) to ‘clearly promote’ generic drugs as a strategy for rational drug use.

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Teva’s hedge with generic enoxaparin versus branded glatimir

Generics/News | Posted 05/02/2010

In the IN VIVO Blog of 14 January 2010, FDC-Windhover’s Biopharma Group Editor-in-Chief Michael McCaughan wrote that – apart from developing a long-term biosimilars strategy (as of 2015) – no one is in quite the same position in complex generics as Teva.

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AstraZeneca, Teva settle Nexium, Prilosec patent disputes

Generics/News | Posted 05/02/2010

AstraZeneca has deferred the threat to its blockbuster drug Nexium (esomeprazole magnesium) in a settlement with Israel's Teva that is likely to delay generic competition for a further four years.

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EU regulators request details of drug patent settlements

Generics/News | Posted 02/02/2010

The European Commission reported on 12 January 2010 that it requested information from several drugmakers in relation to patent settlement agreements made between July 2008 and December 2009.

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Sanofi-aventis still owns clopidogrel users patent for acute coronary syndrome, in contrast to most generic clopidogrels

Generics/News | Posted 01/02/2010

Since the European product patent on sanofi-aventis’ clopidogrel antiplatelet agent Plavixâ – one of the world's best-selling drugs with global sales of US$8.6 billion in 2008, co-marketed with Bristol-Myers Squibb – has expired, several generic clopidogrel products enter the European market. However, sanofi-aventis still owns the usage patent on one of the clopidogrel indications, namely on acute coronary syndrome.

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Will Teva join Big Pharma by 2015?

Generics/News | Posted 25/01/2010

Teva Pharmaceutical Industries’ annual revenue will probably more than double to US$31 billion by 2015, as rising healthcare costs push patients and policy makers toward (bio)generic drugs, Chief Executive Officer, Shlomo Yanai, told analysts on 7 January 2010 in an Internet presentation from New York. According to FiercePharma, that would make it big enough to become one of the Top 10 drugmakers worldwide on the 2008 revenue ranking at least.

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Steady gains in perceptions of generics in Japan

Generics/News | Posted 25/01/2010

As reported by Scrip News on 17 December 2009, the latest survey of patient and pharmacist perceptions of generic drugs in Japan shows a high percentage of patients would be willing to receive such products, while pharmacists view them as important in keeping down healthcare costs.

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EGA warning sounded over generic drug tenders

Generics/News | Posted 12/01/2010

European Generic medicines Association (EGA)’s newly elected President, Mr Didier Barret, called for a “sustainable pricing system” for generic medicines to address unfair competition caused by large-scale government tenders for the products. Mr Barret, who also serves as head of Mylan's operations in Europe, the Middle East and Africa, made the remark as the organisation works on recommendations for expediting the approval of copycat drugs after patent expiration.

India and EU to resolve generic drug dispute

Generics/News | Posted 01/12/2009

India will resolve a dispute with the EU over generic drugs in an amicable way, Trade Minister Anand Sharma said on 6 November 2009.

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EU to seek details of drugmakers' patent deals

Generics/News | Posted 08/12/2009

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.

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Growing generic injectables market: a cousin to biosimilars

Generics/News | Posted 02/12/2009

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.

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Generics drive Dr Reddy's Q2 revenues up 14%

Generics/News | Posted 23/11/2009

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.

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Actavis launches generic challenge to Pfizer’s Lipitor

Generics/News | Posted 29/10/2009

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.

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FDA approves generic prescription-only version of Plan B emergency contraceptive levonorgestrel for women ages 17 and under

Generics/News | Posted 16/10/2009

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.

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Many potential buyers as sale of Ratiopharm begins

Generics/News | Posted 19/10/2009

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

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.

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:

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.