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


Pfizer Norvasc Patent Term Extension Keeps AmVaz Off The Market Until 2007

This article was originally published in The Pink Sheet Daily

Executive Summary

A federal appeals court rules the extended patent protection applies to all salts of amlodipine, including the maleate salt used in Dr. Reddy's antihypertensive agent.

You may also be interested in...

FDA AmVaz Review Could Take Two Months

FDA's re-evaluation of the review for Dr. Reddy's AmVaz (amlodipine maleate) should be completed within two months, the agency says in a Feb. 18 court filing

FDA Takes A Second Look At Dr. Reddy's AmVaz, Will Re-Evaluate Norvasc Competitor

Agency stays approval of product, which has a different salt than Pfizer's amlodipine, following questions about the source of data relied upon during review. Dr. Reddy's had been waiting for an appeals court decision on a patent before launching.

Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies

Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.





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