Please login to the form below

Not currently logged in
Email:
Password:

Shire acts against Sandoz and Amneal

Shire is taking legal action against Amneal and Sandoz for patent infringements

Shire has filed lawsuits in the US District Court for the District of New Jersey against each of Amneal Pharmaceuticals and Sandoz for infringement of Shire's VYVANSE patents.

The lawsuits were initiated in response to abbreviated new drug applications filed by Amneal and Sandoz seeking US Food and Drug Administration (FDA) approval to market and sell generic versions of all currently approved doses of VYVANSE.

Under the Hatch-Waxman Act, the FDA must refrain from approving the Sandoz and Amneal ANDAs for 30 months (expiring August 23, 2014), or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.

Sandoz declined to comment, while Amneal was unavailable to comment at the time of writing.

4th July 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Attigo (part of the Mednet Group)

We are socially intuitive. Attigo deliver inspiring creative healthcare communications, whilst leading the way as partner of choice for socially-conscious...

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

Infographics