Friday, July 24, 2009

Teva, J&J settle over Tri-Cyclen

Reuters quoted &J spokesman Greg Panico: "This settlement compensates us for loss caused by their [Teva's] at-risk launch and recognizes the patent is valid and enforceable," suggesting that Teva was folding the tent on this Hatch-Waxman case [but see below].

Teva gets a license to re-enter the market on December 31, 2015, or earlier in certain circumstances, even though the patent does not expire till 2019.

Of the patent case itself, the Reuters report noted:

Teva said the settlement will not become effective until the U.S. District Court for the District of New Jersey overseeing the case upholds the validity and enforceability of J&J's patent.

Teva had issued a press release on 1 July 09:

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today 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.


Post a Comment

<< Home