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

Bristol-Myers' "exclusive distributor" agreement for OTC rights to Upjohn's ibuprofen NDA means the major players in the OTC analgesic field will stay the same, even if the big Rx analgesic is switched into the OTC category. According to its March 28 announcement of its arrangement with Upjohn, B-M reported that the two firms "have entered into an agreement in which B-M will be the exclusive distributor of Upjohn's analgesic ibuprofen, to be marketed OTC under the brand name Nuprin." Despite its success with Cortaid in the developing OTC hydrocortisone market, Upjohn is deferring to a more established consumer marketing company in the analgesic class. Upjohn is foregoing the heavy costs of a marketing battle against the entrenched analgesic marketers: Bristol, Whitehall, Sterling, and McNeil. Instead, Upjohn will rely on the indirect participation of its license agreement and its manufacturing rights. Bristol and Upjohn noted in the public announcement of the agreement that Upjohn will manufacture the product for Bristol. The Street apparently liked Upjohn's version of valor in the OTC analgesic wars. The issue gained three points during the last week in March, and 1-1/8 points on Wednesday, the day of the announcement. The licensing agreements between Bristol and Upjohn, and Whitehall and Boots give Bristol and Whitehall a leg up in the race to the OTC NDA. However, the other OTC analgesic contestants still have a chance at the ingredient. With the patent expiring on May 28, 1985, any further significant delay in the NDA reviews for Upjohn and Whitehall could allow for almost simultaneous entries by all participants. The OTC NDAs have been tied up by the question of advertising control raised by FDA's advisory cmte. in August and the question of the appropriate method for approval, raised by Chattem. The NDAs are approaching one year at FDA. They were filed in April of last year. McNeil is seeking to limit ibuprofen's impact on the OTC analgesic market by saddling the 200 mg dosage with the Rx label warnings. In a petition submitted to FDA on March 21, McNeil asked for a series of restrictions, including a contraindication for the product OTC in persons allergic to aspirin or suffering from hayfever, asthma or other allergies ("The Pink Sheet" March 26, T&G-11). When it took the Nuprin NDA to the FDA advisory cmte. last August, Upjohn held a press conference to highlight its market estimates for the ingredient OTC. After a predicted slow introduction period, the firm estimated that ibuprofen should take 10%-15% of the total OTC analgesic market.

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

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