Wednesday 8 July, 2009

Bicalutamide (Casodex) 50 mg tablets: Generic approvals

Various generic players have received final approval to market anti-cancer formulation Bicalutamide (Casodex) 50 mg tablets after the expiry of product patent US4636505 (Expiry: Apr 1, 2009) in USA.

Following generic players have got final approval from USFDA:

1. Teva

2. Synthon
3. Kudoco Ireland
4. Sandoz
5. Accord Healthcare
6. Zydus Pharma
7. Sun Pharma
8. Mylan

The generic Bicalutamide (Casodex) 50 mg tablets are bioequivalent to Casodex® tablets from AstraZeneca. As per IMS, Casodex® tablets have annual sales of approximately USD 314 million in the US.


Earlier, innovator has got approval from USFDA to market this product on October 4, 1995.

Bicalutamide (Casodex) 50 mg tablets are an androgen receptor inhibitor for the treatment of Stage D2 metastatic carcinoma of the prostate.

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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)
 
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