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

PUREPAC's GEMFIBROZIL GAINS TENTATIVE APPROVAL

Executive Summary

PUREPAC's GEMFIBROZIL GAINS TENTATIVE APPROVAL Oct. 4, making the Kalipharma subsidiary the first company to get the agency's approval of a generic version of Warner-Lambert's Lopid. The tentative approval is for 300 mg gemfibrozil capsules, a dosage form discontinued by Warner-Lambert earlier this year. Warner- Lambert currently markets a 600 mg tablet of the cholesterol- lowering agent. Purepac says it has a generic version of the 600 mg dosage "in development." When Purepac filed its ANDA for gemfibrozil in 1988, Lopid's patent was set to expire July 4, 1989. However, in 1989, Warner- Lambert was granted a three-and-a-half year patent extension until Jan. 4, 1993. The generics firm is not challenging the Lopid patent and cannot begin marketing generic gemfibrozil until Lopid's patent expires. Lopid is Warner-Lambert's largest source of revenue, with $ 371 mil. in sales in 1990. The company plans to evergreen the drug by marketing an extended-release form, Lopid SR, for which the company filed an NDA in February of this year.

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

OM011381

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