Mylan Announces Ortho Tri-Cyclen Lo® Settlement Agreement
PITTSBURGH, Nov. 8, 2012 /PRNewswire/ -- Mylan Inc. (MYL) today announced that it, along with Famy Care Ltd., has entered into a settlement agreement with Janssen Pharmaceuticals Inc. that will resolve patent litigation related to Norgestimate/Ethinyl Estradiol Tablets 0.180 mg/0.025 mg, 0.215 mg/0.025 mg and 0.250 mg/0.025 mg. Norgestimate/Ethinyl Estradiol Tablets are the generic version of Janssen Pharmaceuticals Inc.'s Ortho Tri-Cyclen Lo® Tablets, which are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.(1)
According to the terms of the settlement, Mylan will be licensed to sell its Norgestimate/Ethinyl Estradiol Tablets 0.180 mg/0.025 mg, 0.215 mg/0.025 mg and 0.250 mg/0.025 mg, on December 31, 2015, or earlier under certain circumstances. Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Ortho Tri-Cyclen Lo Tablets had U.S. sales of $424.5 million for the 12 months ending September 30, 2012, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
(1) Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use and this risk increases with age. Women who use oral contraceptives should be advised to not smoke. Consult your physician prior to beginning oral contraceptive use.