Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Teva Loses Exclusivity On Generic Pravachol; Earlier Court Case Was Trigger

Executive Summary

Teva has nine months to resolve questions surrounding its first-to-file rights for generic pravastatin before the expiration of Bristol-Myers Squibb's exclusivity for Pravachol in April 2006

You may also be interested in...



Pravachol Exclusivity Ruling Adds Uncertainty For ANDA Filers, Counsel Says

A court decision reinstating Teva's generic exclusivity rights for Pravachol will make it more difficult for ANDA filers to predict when a dismissed declaratory judgment action could trigger 180-day exclusivity, FDA Associate Chief Counsel Elizabeth Dickinson said Oct. 26

Pravachol Exclusivity Ruling Adds Uncertainty For ANDA Filers, Counsel Says

A court decision reinstating Teva's generic exclusivity rights for Pravachol will make it more difficult for ANDA filers to predict when a dismissed declaratory judgment action could trigger 180-day exclusivity, FDA Associate Chief Counsel Elizabeth Dickinson said Oct. 26

Generic Exclusivity Forfeiture Provisions Put FDA In “Hot Seat”

FDA is grappling with how to define triggers for forfeiture of generic exclusivity as it develops regulations to implement changes in Hatch/Waxman created by the Medicare Modernization Act of 2003

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS046063

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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