Wednesday, April 18, 2007

Para IV Move: SEROQUEL™ (AstraZeneca/Sandoz)

AstraZeneca has filed a patent infringement complaint in the US District Court for the District of New Jersey against Novartis generic unit – Sandoz alleging infringement of the US 4,879,288 (the ‘288 patent) protecting Quetiapine fumarate, the active ingredient of SEROQUEL, and methods of using that compound. The complaint is result of Sandoz’s Para IV certification for generic SEROQUEL tablets in 25mg strength prior to expiration of the ‘288 patent. On March 22, 2007 Sandoz notified AstraZeneca that it had submitted abbreviated new drug application (ANDA) No. 78-679 to the US FDA seeking approval for commercial manufacturing, using and selling of quetiapine fumarate tablets. The ‘288 patent earlier received a patent term extension under 35 U.S.C. § 156 extending its term for a period of 1,651 days from March 20, 2007 to September 26, 2011.

1 comment:

  1. My name is Kim Collar and i would like to show you my personal experience with Seroquel.

    I am 40 years old. Have been on Seroquel for 9 months now. I would love to know how people sleep after having huge insomnia before seroquel as it is the most potent sleep inducer known to mankind.

    I have experienced some of these side effects-
    lack of motivation, extreme depression, headaches, hypotension, increased pulse, dizziness, weight gain, dry mouth, constipation, personality change, puffy gums, no interest in activities other than sleeping.

    I hope this information will be useful to others,
    Kim Collar

    Seroquel Prescription Medication

    ReplyDelete