Healthcare Industry News: estradiol
News Release - September 7, 2006
Barr Launches a Generic Version of its SEASONALE(R) Extended-Cycle Oral ContraceptiveCompany Confirms That Watson's Generic SEASONALE Application Approved by FDA
WOODCLIFF LAKE, N.J., Sept. 7 (HSMN NewsFeed) -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today 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(TM). The Company launched its generic version of SEASONALE following the final U.S. 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(TM) 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 programs aimed at healthcare providers and patients. Information about SEASONIQUE is available at www.SEASONIQUE.com.
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.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals. The Company is the leading marketer and manufacturer of oral contraceptive products in the United States, based on industry data. The Company currently markets 22 generic oral contraceptive products under its Barr Laboratories, Inc. label and five proprietary (branded) oral contraceptive products under the Duramed Pharmaceuticals, Inc. label.
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2006.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Source: Barr Pharmaceuticals
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