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PTAB Clears Path For Earlier Generic Zytiga Launch

 
• By Brenda Sandburg

Patent Trial and Appeal Board finds that the patent covering the blockbuster prostate cancer drug is unpatentable, which could allow generics to launch at-risk in October once they obtain FDA approval; at least 12 firms have pending ANDAs.

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Johnson & Johnson could face generic competition for its blockbuster prostate cancer therapy Zytiga (abiraterone acetate) as early as October now that the composition and method of use patent covering the drug has been found unpatentable by the US Patent and Trademark Office's Patent Trial and Appeal Board.

On Jan. 17, the Board issued final written decisions in five inter partes review (IPR) cases challenging patent No. 8,822,438,...

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