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

ALZA/MMD BEGIN SHIPPING NICODERM NICOTINE PATCH DEC. 13

Executive Summary

ALZA/MMD BEGIN SHIPPING NICODERM NICOTINE PATCH DEC. 13, the same day a San Francisco Federal court lifted a temporary restraining order barring shipment and sale of the 24-hour transdermal nicotine smoking cessation patch, which was approved by FDA on Nov. 7. After the ruling was announced, Marion Merrell Dow said it would begin shipping Nicoderm "immediately" and that its smoking-cessation patch would be in pharmacies across the U.S. before New Year's day, in time for New Year's stop-smoking resolutions. The company plans to run consumer print, television and radio advertisements for Nicoderm in early 1992. The temporary restraining order had been granted Nov. 21 in response to a request by Elan Corp. and its U.S. marketing partner Lederle in a Nov. 20 patent infringement suit against the Alza/Marion Merrell Dow team. The suit alleged that Nicoderm infringed Elan's patent 4,943,435 for a prolonged activity nicotine patch ("The Pink Sheet" Nov. 25, T&G-4). The TRO was granted pending a decision on Elan/Lederle's preliminary injunction request, which the court also denied on Dec. 13. The patent litigation "will be resolved by the court at a later date," MMD said. No trial date has been set. MMD and Alza said they "vigorously dispute" the patent infringement allegation. Due to the delay caused by the restraining order, Nicoderm will closely follow Ciba-Geigy's Habitrol patch onto the market. Habitrol was approved Nov. 27. Ciba-Geigy said shipments of the product are under way and Habitrol will be in pharmacies across the country by the week of Dec. 23 ("The Pink Sheet" Dec. 9, T&G- 1). Ciba-Geigy escaped an immediate threat to Habitrol's introduction on Dec. 11 when a Newark, N.J. federal court denied Elan/Lederle's request for a temporary restraining order against the product. Elan/Lederle's request was part of the two companies' counterclaim against Ciba-Geigy, which sued them for patent infringement on Dec. 2. Ciba-Geigy also had requested a temporary restraining order against Elan/Lederle's ProStep patch, which is unapproved, but that request was denied on Dec. 11 as well. The Newark federal court is scheduled to rule on Elan/Lederle's request for a preliminary injunction on Dec. 20 and on Ciba- Geigy's request on Jan. 28. Ciba-Geigy's suit against Elan and Lederle further clouds the nicotine patch litigation picture, with all four competitors involved in at least one patent infringement suit each. In addition to its suit against Elan and Lederle, Ciba-Geigy sued Alza/MMD on Nov. 27 ("The Pink Sheet" Dec. 9, T&G-2). Elan/Lederle also have a suit pending against Cygnus Therapeutic Systems alleging that Nicotrol 16, which was codeveloped with Kabi Pharmacia and uses Cygnus' matrix technology, infringes Elan's 4,946,853 method patent ("The Pink Sheet" May 20, T&G-4). Nicotrol 16 is to be marketed by Warner-Lambert.

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

MT101489

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