Barr Allegra-D generic
Executive Summary
Barr is free to launch the first generic version of Sanofi-Aventis' Allegra-D 12 hour tablets (fexofenadine/pseudoephedrine) following final FDA approval announced April 14. A launch would be "at risk" because of ongoing patent litigation. Approval of Barr's ANDA comes shortly after the company and FDA resolved a dispute over the agency's original decision to split the 180-day exclusivity for generic Allegra-D between Barr and Impax. Barr's withdrawal of a Paragraph IV certification against a late-listed Sanofi-Aventis patent (6,399,632) made it eligible for sole exclusivity and nullified the only remaining 30 month stay...
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Barr Allegra approval
Barr receives first ANDA approval for generic equivalent to Sanofi-Aventis'Allegra 60 mg capsules July 13. Barr maintains it is the first to file an ANDA for fexofenadine and is therefore entitled to a 180-day exclusivity period. Barr remains in litigation with Sanofi in New Jersey district court over five Allegra patents; the firm says the case may go to trial in early 2006. Barr was approved by FDA to market Allegra-D (fexofenadine/pseudoephedrine) generics in April, but has not yet launched the product (1"The Pink Sheet" April 18, 2005, In Brief)...
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Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.