News & Analysis as of

Anti-Competitive Federal Trade Commission (FTC) Abbreviated New Drug Application (ANDA)

Arnall Golden Gregory LLP

FDA Issues Final Guidance on “505(q)” Citizen Petitions, including Factors to be considered in Evaluating Potential...

FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications....more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

McDermott Will & Emery

Third Circuit Extends Actavis to Reverse Settlement Agreements Involving Non-Cash Consideration - King Drug Company of Florence,...

Addressing for the first time whether reverse settlement agreements involving non-cash consideration merit antitrust scrutiny, the U.S. Court of Appeals for the Third Circuit reversed the district court, applying the...more

Fenwick & West LLP

Litigation Alert: Supreme Court Rules on “Reverse Payment” Settlements in Federal Trade Commission v. Actavis, Inc.

Fenwick & West LLP on

Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more

McDonnell Boehnen Hulbert & Berghoff LLP

Par/Paddock Answers FTC Before Supreme Court

Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more

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