Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Patent Litigation Settlements Should Be Filed With FDA, FTC Says

Executive Summary

FDA's 180-day ANDA exclusivity rule should require patent litigation settlements between branded companies and ANDA applicants to be filed with FDA, the Federal Trade Commission suggested in comments on FDA's proposed rule.

You may also be interested in...



Gore Pro-Generic Campaign Platform Includes Citizen Petition Restrictions

Vice President Gore is promising to address the potential for the FDA citizen petition process to be used to delay generic drug approvals if he is elected President.

Gore Pro-Generic Campaign Platform Includes Citizen Petition Restrictions

Vice President Gore is promising to address the potential for the FDA citizen petition process to be used to delay generic drug approvals if he is elected President.

ANDA Reformulations Should Not Result In Loss Of 180-Day Exclusivity - Andrx

Reformulation of a product under ANDA review should not result in the loss of 180-day exclusivity eligibility, Andrx argued in Oct. 5 comments to FDA's 180-day generic exclusivity proposed rule.

Related Content

UsernamePublicRestriction

Register

PS035172

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel