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

Rx or OTC for generic desloratadine

This article was originally published in The Tan Sheet

Executive Summary

Generic pharmaceutical firm Mylan may market desloratadine tablets (5 mg) in the U.S. beginning in July 2012 in direct competition with Schering-Plough's Clarinex allergy medication, according to a patent litigation settlement announced April 8. Pending FDA's approval of Pittsburgh-based Mylan's abbreviated new drug application, the firm can market the tablets as Rx or OTC depending on the status at the time for Clarinex, which is considered a likely switch candidate (1"The Tan Sheet" Feb. 4, 2008, p. 5). Sales of desloratadine tablets (5 mg) reached $284 million in the U.S. during 2008, according to IMS Health

You may also be interested in...



Morgan Stanley Analysts Handicap Potential Switches In Near Future

With the potential to cash in on up to $10 billion in branded sales in the next five years, a number of prescription drugs are positioned to break into the OTC market by 2012, Morgan Stanley analysts say

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 

Topics

UsernamePublicRestriction

Register

LL1126093

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