Barr Pharmaceuticals, Inc. announced that its subsidiary Barr Laboratories, Inc. is launching a generic version of the company's proprietary Seasonale extended-cycle oral contraceptive under the tradename Jolessa.
The company launched its generic version of Seasonale following the final US Food and Drug Administration (FDA) approval of Watson Laboratories, Inc.'s Abbreviated New Drug Application (ANDA) for Seasonale. Watson received approval following the expiration of the Company's 3-year New Product Exclusivity on September 5, 2006.
"While issues related to our application with the Patent and Trademark Office to reissue the patent covering Seasonale are being resolved, we will take those steps appropriate to defend our interests in this proprietary product," said Bruce L. Downey, Barr's chairman and CEO. "It is our obligation to preserve our rightful interests in this product, as well as continue the promotion of our Seasonique extended-cycle oral contraceptive, which represents the next generation in a category we created with the approval and launch of Seasonale."
In May 2006, Barr received approval for its Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the prevention of pregnancy. Seasonique represents the next generation of extended-cycle oral contraceptives in a category the company created with the launch of the Seasonale extended-cycle oral contraceptive in 2003. Seasonique was shipped to trade customers and was available by prescription to women in July 2006. The company initiated full scale detailing for Seasonique to healthcare providers in August using its Duramed Sales Forces. The Company immediately initiated multiple marketing programmes aimed at healthcare providers and patients.
In June 2004 the company announced that it received notification that Watson Laboratories, Inc. had filed an ANDA containing a paragraph IV certification asserting that the patent covering Seasonale is invalid, unenforceable or would not be infringed by Watson's generic product. Barr did not initiate patent infringement litigation with respect to Watson's ANDA. In July 2004, Barr filed an application seeking reissue of the '032 patent with the Patent and Trademark Office (PTO) in July 2004. In May 2006, the Company received a Non-Final Rejection notice from the PTO and in July 2006 responded to the issues raised by the PTO in its Non-Final Rejection. The PTO continues to evaluate the Company's application for reissuance and in the meanwhile the '032 patent remains in effect and continues to be listed in the FDA's Orange Book.