Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced the launch of a generic equivalent of Ortho Tri-Cyclen® Lo (norgestimate/ethinyl estradiol) tablets in the United States. Teva’s Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets, USP) is an oral contraceptive, available in a 28-day blister pack dispenser, used by women to prevent pregnancy.
As a leading global pharmaceutical company, Teva is committed to care in women’s health with a portfolio including contraceptive products and other therapies.
Ortho Tri-Cyclen® Lo (norgestimate/ethinyl estradiol) tablets, marketed by Janssen Pharmaceuticals, Inc., had annual sales of approximately $488 million in the United States, according to IMS data as of October 2015.
Tri-Lo-Sprintec is indicated for use by females of reproductive potential to prevent pregnancy. Tri-Lo-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Important Safety Information
Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke.
Tri-Lo-Sprintec is contraindicated in women who are known to have the following conditions: a high risk of arterial or venous thrombotic diseases; liver tumors, benign or malignant, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Serious adverse reactions associated with the use of COCs include: thromboembolic disorders and other vascular problems; impaired liver function or liver tumors; hypertension, gallbladder disease; carbohydrate and lipid metabolic effects; new or worsening of headaches, including migraines; bleeding irregularities and amenorrhea, depression; carcinoma of breast and cervix; elevations of binding globulins, angioedema, and chloasma.
The most common adverse events reported during clinical trials (≥2%) were: headache/migraine, nausea/vomiting, breast issues, abdominal pain, menstrual disorders, mood disorders, acne, vulvovaginal infection, abdominal distension, weight increased, and fatigue.
For more information, please see accompanying full Prescribing Information, including Boxed Warning.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2014 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
Tomer Amitai, 972 (3) 926-7656
Iris Beck Codner, 972 (3) 926-7687
Denise Bradley, 215-591-8974
Nancy Leone, 215-284-0213