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

Provigil Generic Exclusivity Dispute Keeps Lawyers Up At Night

This article was originally published in The Pink Sheet Daily

Executive Summary

Teva dropped its suit when FDA conceded the firm has 180-day marketing exclusivity for generic Provigil; Mylan then sued the agency claiming Teva lost its exclusivity rights with its acquisition of Cephalon.

You may also be interested in...



FDA Hit With Slew Of Suits As Firms Fight For Market Advantage

At least nine complaints have been filed against the agency since March, most involving market exclusivity claims; lawyers expect innovators will be pursuing more cases as patents expire and biosimilars emerge.

Where’s Generic Diovan? Ranbaxy’s Valsartan ANDA In Limbo As Novartis’ Patent Expires

Apparent first-filer Ranbaxy failed to receive ANDA final approval upon expiration of Novartis’ compound patent for the antihypertensive, raising questions as to whether the Indian company’s opportunity on generic Diovan will be compromised by its GMP consent decree with FDA.

Where’s Generic Diovan? Ranbaxy’s Valsartan ANDA In Limbo As Novartis’ Patent Expires

Apparent first-filer Ranbaxy failed to receive ANDA final approval upon expiration of Novartis’ compound patent for the antihypertensive, raising questions as to whether the Indian company’s opportunity on generic Diovan will be compromised by its GMP consent decree with FDA.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073982

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