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

Andrx Expects “Near Term” FDA Response To Petition Blocking Concerta Generics

This article was originally published in The Pink Sheet Daily

Executive Summary

McNeil’s citizen petition requests FDA apply additional bioequivalence requirements for Concerta ANDAs. With no patent exclusivity remaining on the innovator product, multiple generics could be approved if FDA rejects McNeil’s arguments.

You may also be interested in...



J&J Dismisses Concerta Patent Suit Against Impax

"Odd" case against the first-filer ends, but litigation with Andrx continues.

J&J Dismisses Concerta Patent Suit Against Impax

"Odd" case against the first-filer ends, but litigation with Andrx continues.

Shire Citizen Petition Seeks to Block Adderall XR Generics

The timing of Shire's petition likely was influenced by the forthcoming end of the 30-month stay on Barr's ANDA.

Related Content

Topics

UsernamePublicRestriction

Register

PS060261

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