Scrip 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

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

Executive Summary

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.

You may also be interested in...



Patent Litigation Settlements Should Be Filed With FDA, FTC Says

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.

Patent Litigation Settlements Should Be Filed With FDA, FTC Says

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.

Purepac Challenges Andrx Cardia XT Exclusivity On Reformulation Grounds

A first-to-file ANDA applicant should lose its eligibility for 180-day exclusivity if it makes major changes to the application at a later date, Purepac asserts in a petition to FDA requesting that Andrx be stripped of its exclusivity for generic sustained-release diltiazem, equivalent to Hoechst Marion Roussel's Cardizem CD.
UsernamePublicRestriction

Register

PS035029

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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