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


Trump's Budget Request To Include ANDA Exclusivity Changes

Executive Summary

180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.


Related Content

Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity
Are 180-Day Exclusivity Changes Moving Out Of Drug Pricing Plans?
Groundhog Day For HHS And Drug Pricing? Why It Might Be Different This Time
Trump Emphasizes Foreign Drug Prices At Alex Azar's Swearing In
New ANDA Review Pathways: Should You Be A Priority Or Expedited?
Pay-For-Delay, REMS Reform Legislation Making (Slow) Progress In House
Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff
Trump's Budget Outline Threatens User Fee Agreements
US FDA Gives Directions On Navigating Generic 180-Day Exclusivity Maze
CMS 2012 Budget Looks To Biosimilars, Brand/Generic Deals To Offset Costs





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