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Latest From Watson Laboratories Inc.

ANDA Case Filings Drop 32%, But Still High Compared To Last Decade

Lex Machina reports that 316 ANDA cases were filed in 2016 compared to 468 in 2015; number of inter partes review petitions filed on Orange Book patents has declined since 2015.

BioPharmaceutical Policy

GDUFA II: More Than 2,000 ANDAs Remain Unclaimed, Large Firms Still Dominate

Firms could find themselves charged multiple US generic drug user fees if affiliates are not identified and ANDAs claimed.

FDA Generic Drugs

Novartis Exelon Patch Patent Battle: PTAB Can Disagree With District Court

Federal Circuit rejects Novartis argument that Patent Trial and Appeal Board unlawfully concluded Exelon patents were unpatentable after a district court upheld them.

BioPharmaceutical Policy

Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals
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