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
Improved reporting for generics
The UK Medicines and Healthcare products Regulatory Agency (MHRA) published on 14 March 2012 its fifth report on the Better Regulation of Medicines Initiative (BROMI).
The aim of the initiative is to reduce the burden on companies, whilst ensuring public health is protected. The UK generics industry association, the British Generic Manufacturers Association (BGMA), has been collaborating with MHRA on the initiative. The BROMI approach has been used to proactively address potential burdens in delivery of communications by generics companies and has made an estimated GBP 500,000 in savings in the process.
Source: MHRA
Ranbaxy opens new manufacturing facility in Morocco
Ranbaxy Morocco announced on 12 March 2012 the opening of its new manufacturing facility in Casablanca, Morocco, paving the way for a direct business presence in North Africa.
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Actavis launches generic migraine treatment zolmitriptan
Icelandic generics manufacturer Actavis announced on 7 March 2012 that it had launched a generic version of AstraZeneca’s migraine treatment Zomig (zolmitriptan) in the UK. The UK patent on Zomig expired at midnight on 6 March 2012.
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