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



Executive Summary

BIOCRAFT INITIATES FIRST PATENT CERTIFICATION PROCEDURE under the Waxman/Hatch Law in filing a post-1962 ANDA for a generic version of Merck's still-patented Moduretic. In an Oct. 21 press release, Biocraft announced that its ANDA, submitted to FDA on Oct. 15, included a certification that it believes Merck's composition and use patents for the amiloride HCl/hydrochlorothiazide combination product are invalid. "As part of its ANDA, Biocraft has certified to FDA that it believes Merck's patent for Moduretic is invalid," the generic firm said. "Biocraft has notified Merck of its position," as required by the year-old-law, the firm added. Under the Waxman/Hatch legislation, Merck has 45 days to respond to the patent challenge by requesting a declaratory judgment in federal court. If the litigation is not resolved after 30 months, Biocraft would have the option to begin marketing its product at risk. the ANDA/patent law provides Biocraft, if its patent challenge prevails, with six months of exclusivity as the sole generic mfr. of the product. In the negotiations on the Waxman/Hatch bill last year, Biocraft President Harold Snyder was one of the strongest proponents of the provision granting six months exclusivity for a successful patent challenge.

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




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