Thursday 19 March, 2009

Minocycline HCl (Solodyn) 45, 90 and 135 mg ER tablets: Innovator Medicis settled with Teva; generic launch expected in 2011

Innovator Medicis and Teva Pharma announced (in press release here) that they have agreed to terminate all legal disputes between them relating to SOLODYN(R) (Minocycline HCl, USP) Extended Release Tablets. Pursuant to an agreement entered into between the parties, Teva has confirmed that Medicis' patents relating to SOLODYN(R) are valid and enforceable, and cover Teva's activities relating to its generic product under Abbreviated New Drug Application (ANDA) #65-485.

Following patents was listed in Orange Book for this product (on Dec 5, 2008 as per § 4(b)(1) of the QI Program Supplemental Funding Act of 2008 for old antibiotic products):
US5908838 (Expiry: Feb 19, 2018): which 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).
Various generic players like Impax, Matrix, Sandoz and Barr have amended their ANDA (after patent listing as per Q1 programme for old antibiotic products patent listing in Orange Book) and filed Para IV against said patent, subsequently, innovator sued these generic players in Delaware district court (as reported earlier by IPPharmadoc Here, Here, here).

Eralier, Teva announced in a press release (Link to news Here) about final approval from USFDA on this product and shipment of this product in US market.
As part of the settlement, Teva has agreed to immediately stop all further shipments of generic SOLODYN(R). Medicis has agreed to release Teva from liability arising from any prior sales of its generic SOLODYN(R), which were not authorized by Medicis.
Under the terms of the Settlement Agreement, Teva has the option to market its generic versions of SOLODYN(R) 45mg, 90mg and 135mg under the SOLODYN(R) intellectual property rights belonging to Medicis commencing in November 2011, or earlier under certain conditions. Additional terms were not disclosed.

The innovator got final approval to market this product for 45, 90 and 135 mg strengths on May 8, 2006.
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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