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Also noted on generics: 22 March 2012

Watson confirms patent challenges
Watson Pharmaceuticals (Watson) confirmed that lawsuits had been filed against the generics company regarding two Abbreviated New Drug Applications it had submitted to FDA.

Forest Laboratories filed a lawsuit against Watson on 13 March 2012 to try to prevent a generic version of Bystolic (nebivolol) used for treatment of hypertension, until the ‘040’ patent that Forest licenses from Janssen Pharmaceutica expires in December 2021.

Abbott Laboratories filed a lawsuit against Watson on 16 March 2012 to prevent commercialisation of a generic version of Niaspan (Niacin) extended release tablets until the ‘428’ and ‘035’ patents expire in September 2013.

Source: Watson

Generics saved Germany more than 25% in 2011

The increased use of generics in Germany has brought about record savings of more than 25% in 2011 compared with 2010. The increased savings have been attributed to the success of measures put in place by the German Government to encourage generics substitution and competition in the public health insurance funds off-patent market.

Generics reach 80% and play a critical role in reducing costs

Prescription drug spending in the US reached US$307 billion in 2010–an increase of US$135 billion since 2001–and comprised approximately 12% of all healthcare spending in the country, according to a report published on 31 January 2012 by the US Government Accountability Office (GAO).

Indian Government issues first compulsory licence

The Indian Government has issued a compulsory licence for the first time, allowing India-based drugmaker Natco Pharma (Natco) to launch a generic version of Bayer’s liver and kidney cancer drug Nexavar (sorafenib) before the patent expires on the originator.

Also noted on generics: 16 March 2012

Prescription drugs to be directly dispensed by pharmacists
FDA has announced a meeting to be held on 22 and 23 March 2012 to discuss the possibility of allowing some prescription drugs to be dispensed by pharmacists without the need for a physician’s prescription.

Source: Federal Register

FDA approves new suppliers to alleviate cancer drug shortages

Two new suppliers of cancer treatments have been approved by FDA to try to alleviate ongoing US drug shortages.

WHO definitions of generics

Confusion often surrounds terms used in the global field of generics and biosimilars.

Commission urges Greece to make parallel trade fair

The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’.

Italian physicians’ negative attitude to generics

A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.

The pharmaceutical market in Brazil

The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.

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