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
UsernamePublicRestriction

NIFEDIPINE FIRST GENERIC APPROVAL GRANTED TO PUREPAC; EFFECTIVE DATE

Executive Summary

NIFEDIPINE FIRST GENERIC APPROVAL GRANTED TO PUREPAC; EFFECTIVE DATE of the ANDA approval, however, is delayed until an as-yet-undetermined date because of ANDA exclusivity that may be granted to another company. Purepac received approval for nifedipine 10 and 20 mg caps (Pfizer's Procardia and Miles' Adalat) on April 28. Under provisions of the Waxman/Hatch law, the first company to submit an ANDA for a generic drug and successfully challenge the innovator's patent is entitled to 180 days of marketing exclusivity, starting from either the date of its approval or the date of a court ruling of noninfringement. FDA explained in its approval letter to Purepac that an undisclosed generic firm submitted its nifedipine marketing application prior to Purepac and is currently in litigation with Pfizer over the validity of the nifedipine patent, which expires in January 1991. "Because of this litigation, the effective date of approval of your application must be delayed until a ruling by a court that the patent is invalid or will not be infringed, or the drug product which is the subject of this previously submitted application is the first commercially marketed, whichever is earlier," FDA told the generic company. The patent reportedly covers formulation of the drug. Purepac is also still in litigation with Pfizer over the nifedipine patent. Purepac's approval marks the second time that a generic firm has been delayed from entering the market by ANDA exclusivity provisions when the exclusivity holder had not yet received its ANDA approval. American Therapeutics received the first approval for a generic version of Lederle's Maxzide in November 1987, but was prevented from marketing because of an exclusivity grant to Vitarine. Vitarine subsequently received ANDA approval in December, starting off the 180-day exclusivity time clock.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

PS015560

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

Cancel