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

Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

Executive Summary

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

You may also be interested in...



Pharma On Its Back Foot As US Drug Price Reform Advances

Big pharma leaders warn of steep cuts to R&D and US jobs if US drug pricing reform legislation paves the way for direct government price negotiations.

Drug Pricing Activity At US FDA May Be Unique To Gottlieb Tenure

Steven Grossman argues that the former commissioner possessed the credentials to be out front on the pricing issue, unlike other recent FDA commissioners and the current holder of the office.

ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity

Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144958

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