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

Boehringer Ingelheim's once-a-week transdermal Catapres-TTS will begin sales in "early 1985," Boehringer and Alza stated in an Oct. 15 joint release announcing FDA approval of the antihypertensive. The U.S. is the first country to approve the transdermal formulation of the antihypertensive, although licenses are reportedly pending in several other countries. The Catapres transdermal therapeutic system was developed by Alza using Alza's patch delivery drug technology, under a royalty-bearing license agreement with Boehringer Ingelheim's parent, C. H. Boehringer Sohn. Under the agreement, Alza will manufacture the drug and Boehringer will market it. FDA approved the drug within two years of Boehringer's NDA submission in November 1982. Boehringer will get at least three years of marketing exclusivity in the U.S. for patch clonidine under the recently passed ANDA/Patent Restoration law's provision for a three-year moratorium on abbreviated new drug applications for NDAs that are not new chemical entities, but require clinical trials. Labeling cautions that "in patients who have developed contact sensitization to Catapres-TTS, substitution of oral Catapres therapy may be associated with development of a generalized skin rash." Adverse reactions with transdermal clonidine are similar to reactions with the oral formulation. Alza noted that the benefits of Catapres-TTS over oral clonidine include increased compliance and a reduction in side effects, since the patient receives less drug. According to the Catapres-TTS labeling, therapy should be initiated with Catapres-TTS-1, which delivers 0.1 mg of clonidine per day. Labeling for the oral formulation calls for initial therapy of 0.1 mg twice a day. Catapres-TTS-1, Catapres-TTS-2, and Catapres-TTS-3 are supplied as four pouched systems with four adhesive overlays per carton. Labeling notes that "the 3.5, 7.0, and 10.5 cm systems respectively deliver 0.1, 0.2, and 0.3 mg clonidine per day." The whslr. price for the three systems is $36 for 12 (0.1), $60.60 for 12 (0.2), and $28 for 4 (0.3), respectively.

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