Friday 26 December, 2008

Quetiapine Fumarate: Teva got tentative approval

Teva Pharma announced today that the United States Food and Drug Administration (USFDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's antipsychotic agent Seroquel® (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base.

The brand product had annual sales of approximately $3.8 billion in the United States for the twelve months that ended September 30, 2008, based on IMS sales data.

It is pertinent to mention here that generic players like Teva and Sandoz tried to invalidate inoovator Astra’s Orange Book listed product patent US4879288 (Expiry: September 26, 2011) in New Jersey District court. However, court upheld the validity of said patent. Teva can launch its generic version of Quetiapine after September 26, 2011.

No comments:

web page statistics
Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
eXTReMe Tracker