Search Results for pay-for-delay

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Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition By Zachary Brennan - Published 08 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition.

Categories: News, US, FDA, FTC, Generic drugs, Government affairs, Reimbursement

Tags: generic drug competition, REMS, shared REMS, pay-for-delay

Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling By Zachary Brennan - Published 01 November 2017

The total number of deals in which brand name drugmakers pay to delay the entry of generic competitors continues to decline, and only 5 of the 170 final settlements in FY 2015 included compensation to the generic and a restriction on generic entry, the Federal Trade Commission (FTC) said in a report released Wednesday.

Categories: News, US, FTC, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: pay-for-delay deals, generic delays

FTC Continues Crackdown on Pay-for-Delay Agreements By Zachary Brennan - Published 23 January 2017

The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements that often keep generic drugs from entering the US market.

Categories: News, US, FTC, Generic drugs, Due Diligence, Government affairs, Regulatory strategy

Tags: pay-for-delay settlements, Endo, Allergan, Watson Laboratories, Impax

Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic By Zachary Brennan - Published 28 September 2016

Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Medical Devices, Regulatory strategy

Tags: Mylan, Teva, EpiPen, Patty Murray, citizen petition, pay-for-delay settlement

FTC Sues Drugmakers for Not Marketing Authorized Generics By Zachary Brennan - Published 31 March 2016

The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws.

Categories: News, US, FTC, Compliance, Crisis management, Government affairs, Product withdrawl and retirement

Tags: FTC, no-AG commitments, pay-for-delay, generic entry, exclusivity

FTC: Pay-For-Delay Deals Decrease Significantly After Supreme Court Ruling By Zachary Brennan - Published 14 January 2016

The number of pay-for-delay settlements decreased significantly in 2014 after a Supreme Court decision in 2013 found that a branded drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate antitrust laws.

Categories: News, US, FTC, Drugs, Ethics, Government affairs, Regulatory strategy

Tags: FTC, pay-for-delay, generic competition

GSK Investigated for 'Pay-for-Delay' Agreements in UK By Alexander Gaffney, RF News Editor - Published 19 April 2013

Tags: Competition, GSK, Pay-For-Delay, Pay For Delay, UK

Bill Seeks to End Pay-for-Delay Agreements By Alexander Gaffney, RF News Editor - Published 06 February 2013

Categories: FTC

Tags: Settlement, Pay-For-Delay, Pay For Delay, Patent, drug

FTC Report Indicates Pay-for-Delay Deals on the Rise By Alexander Gaffney, RF News Editor - Published 18 January 2013

Categories: FDA, FTC

Tags: Pay-For-Delay, Pay For Delay, Report

FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases By Alexander Gaffney - Published 05 October 2012

Categories: FDA, FTC

Tags: Writ of Certiorari, Pay-For-Delay, Pay For Delay, Lawsuit, Court, SCOTUS, Latest News, Supreme Court

European Trade Regulators Charge Companies for 'Pay-for-Delay' Agreements By Alexander Gaffney - Published 26 July 2012

Tags: Lundbeck, Competition, Pay-For-Delay, Servier, Generic, Latest News

Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal By Alexander Gaffney - Published 17 July 2012

Categories: FDA, FTC

Tags: Leibotiz, Pay-For-Delay, Pay For Delay, Lawsuit, Court, Amicus Curiae, Latest News

Reps. Waxman, Rush Introduce Bill to Stop 'Pay-For-Delay' Settlements By Alexander Gaffney - Published 13 February 2012

Tags: 180-Day Exclusivity, Rush, Settlement, Pay-For-Delay, Pay For Delay, Waxman, Generic, ANDA, Latest News, Bill, Congress