Teva Announces Approval And Launch Of Tri-Lo Sprintec Tablets

Main Category: Pregnancy / Obstetrics
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 02 Jul 2009 - 1:00 PDT

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen® Lo. Shipment of this product, for which Teva's trade name is Tri-Lo Sprintec, has commenced.

As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

Annual sales of Ortho Tri-Cyclen® Lo were approximately $400 million in the United States for the twelve months that ended March 31, 2009 based on IMS sales data.

Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.

Source
Teva Pharmaceutical Industries Ltd.