Wednesday, generic pharmaceutical company Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration, or FDA, has granted marketing approval for its Abbreviated New Drug Application, or ANDA, to market Ortho Tri-Cyclen Lo, a generic version of Ortho McNeil Janssen's oral contraceptive.
Teva also got a 180-day period of marketing exclusivity, since it is the the first company to file an ANDA containing a paragraph IV certification for the product.
For the year, according to IMS sales data, Ortho Tri-Cyclen Lo's annual sales was about $400 million in the United States.
Israel-based Teva has started shipment of Ortho Tri-Cyclen Lo with the trade name Tri-Lo Sprintec. The company is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey.
TEVA closed Tuesday's regular trading at $49.34 on the Nasdaq.
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