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


FDA Changes Its Policy On Exclusivity For Fixed-Combination Products

This article was originally published in The Pink Sheet Daily

Executive Summary

In response to citizen petitions from Gilead, Ferring and Bayer, FDA issued a draft guidance saying future fixed-combination products that include a previously approved active moiety will be eligible for five years of new chemical entity marketing exclusivity.

You may also be interested in...

Fixed Combinations Of ‘Old Antibiotic’ Plus New Moiety Eligible For NCE Exclusivity, US FDA Says

A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.

NME Exclusivity Petitions Expand; Ferring Request For Colon-Cleansing Combo Has Urgency

Ferring requests five years of marketing exclusivity for Prepopik; Gilead also has asked FDA to award five years of exclusivity for active ingredients in a combination product that has not been previously approved, but Gilead has patents to fall back on while Ferring has none.

Gilead Compares Stribild To Prezista In Seeking Exclusivity For Fixed Dose Combinations

Gilead requests five-year marketing exclusivity for two of the components in its HIV Quad treatment Stribild; citizen petition says award should not depend on whether a new active moiety is approved first as a single entity product or as part of a fixed-dose combination.


Related Companies




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