Innovator Medicis has sued Indian pharma giant Ranbaxy in Delaware District court for filing ANDA with Paragraph IV certification against following Orange Book listed patent for Minocycline HCl (Solodyn) 45, 90 and 135 mg ER tablets:
US5908838 (Expiry: Feb 19, 2018): The patent covers method for reducing the incidence or severity of vestibular side effects resulting from the treatment of acne by the use of oral tetracycline antibiotics, comprising administering the oral tetracycline antibiotic (including Minocycline hydrochloride) in a slowly dissolving dosage form (patent covers primary indication).
The above patent was listed in Orange Book on Dec 5, 2008 as per § 4(b)(1) of the QI Program Supplemental Funding Act of 2008 for old antibiotic products. Earlier, old antibiotics approved before November 21, 1997 were not listed in Orange Book
Various generic players like Impax, Matrix and Sandoz have also filed Para IV against said patent, subsequently, innovator sued these generic players in Delaware district court and litigation is ongoing with these generic players.
Earlier, Generic player Teva (Barr) has settled pending litigation with innovator on this product in March, 2009 (as reported by IP Pharma doc Here ) and agreed to launch this product from November, 2011 onwards.
Annual sales of this product were approximately $365 million in the United States for the twelve months that ended January 31, 2009, based on IMS sales data
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