Pink Sheet is part of the Informa Intelligence Division 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

Generic Firms Break Camp; FDA Says “First-To-File” Covers Same-Day ANDAs

Executive Summary

FDA's guidance defining "first-to-file" status for generic drug companies launching patent challenges offers some relief for ANDA applicants jockeying for position at the agency - and may offer a further impetus for changes to the current 180-day exclusivity system
Advertisement

Related Content

Lipitor Watch: Pfizer Hangs On To Share, But At What Cost?
FDA First-Generic Notification Policy May Be Reviewed
FDA First-Generic Notification Policy May Be Reviewed
Barr Would Share Generic Provigil Exclusivity Under FDA’s Revised Guidelines
Barr Would Share Generic Provigil Exclusivity Under FDA’s Revised Guidelines
Generic Drug 180-Day Exclusivity Provisions: Hatch Seeks CBO Score
FDA Questions First-To-File Exclusivity As Generic Reforms Pass Senate
Advertisement
UsernamePublicRestriction

Register

PS042235

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