Innovator AstraZeneca today announced that the USFDA has granted an additional six-month Pediatric Exclusivity to market Casodex (Bicalutamide) 50 mg tablets, which is used for the treatment of advanced prostate cancer. Following patent is listed in Orange Bookf for Bicalutamide 50mg tablets:
US4636505 (Expiry: Apr 1, 2009): Which covers Bicalutamide as product
This drug was approved by USFDA on Oct 4, 1995 for 50 mg tablets. The earlier expiry of '505 patent was Oct 1, 2008.
As per USFDA records, only one generic company Sandoz has got tentative approval on February 11, 2008 for this product. With this decision, the generic launch for this drug has delayed by 6 months. Now, a generic version of this formulation will be available from April 2, 2009 onwards
US4636505 (Expiry: Apr 1, 2009): Which covers Bicalutamide as product
This drug was approved by USFDA on Oct 4, 1995 for 50 mg tablets. The earlier expiry of '505 patent was Oct 1, 2008.
As per USFDA records, only one generic company Sandoz has got tentative approval on February 11, 2008 for this product. With this decision, the generic launch for this drug has delayed by 6 months. Now, a generic version of this formulation will be available from April 2, 2009 onwards
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