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

Generic Exclusivity Debate Continues At FDA: What Counts As A Forfeit?

Executive Summary

FDA is continuing its case-by-case review of the 180-day exclusivity status for ANDAs as they approach marketing - most recently for generics of Bayer's Precose (acarbose), King's Altace (ramipril) and Roche's Kytril (granisetron)

You may also be interested in...



Altace ANDAs On Hold Till June; Colbalt Gets Exclusivity, Not “Parking” Ticket

Lupin Pharmaceuticals and five other pharma companies will have to wait at least until June to market their versions of ramipril capsules (King's Altace), as FDA ruled that Cobalt Pharmaceuticals is entitled to the 180-day generic drug exclusivity it was granted in 2005

Altace ANDAs On Hold Till June; Colbalt Gets Exclusivity, Not “Parking” Ticket

Lupin Pharmaceuticals and five other pharma companies will have to wait at least until June to market their versions of ramipril capsules (King's Altace), as FDA ruled that Cobalt Pharmaceuticals is entitled to the 180-day generic drug exclusivity it was granted in 2005

Generic Exclusivity Triggers May Force Re-evaluation Of Brand/Generic Deals

FDA's consideration of how brand/generic settlements would impact generic exclusivity may be causing firms to reconsider the arrangements

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS048911

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