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

Purdue Looks To Patent Portfolio, FDA Guidance To Delay OxyContin Generics

This article was originally published in The Pink Sheet Daily

Executive Summary

Federal Circuit finds four OxyContin patents invalid, but authorized generics will continue to be only ones available for the near future.

You may also be interested in...



Califf Nomination Suffers 'Pile On': What Can FDA Do To Break Logjam?

Sen. Alexander and others remain optimistic as several holds and a filibuster threat emerge.

FDA Sets New Goal For Biosimilar, Drug Promotion Guidances

Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.

OxyContin Patent Settlement Limits Impax Market Share Even With ANDA Approval

Generic manufacturer could begin selling either its own product or an authorized generic of the controlled-release opioid as early as Jan. 1, 2016.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079133

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