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Article III › Sandoz

Dechert LLP

District of Delaware Holds that ANDA Filer’s Conversion from a PIV Certification to a PIII Certification Does Not Strip Court of...

Dechert LLP on

Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more

Patterson Belknap Webb & Tyler LLP

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Patterson Belknap Webb & Tyler LLP on

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

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