Bayer HealthCare Sues Teva Pharmaceutical Industries Limited and Barr Pharmaceuticals, Inc. for False Advertising and Patent Infringement in Connection with Teva's Generic Oral Contraceptive Gianvi(TM)
Published: Jun 16, 2010
YAZ® tablets contain an estrogen (17alpha-ethinylestradiol) stabilized by beta-cyclodextrin (or "betadex") as a "clathrate" (a protective molecular cage). Using betadex as a clathrate improves stability and prolongs shelf life of the product. Bayer believes Teva is offering for sale its Gianvi product with Physician Prescribing Information that falsely claims that Gianvi's ethinyl estradiol is "stabilized by betadex as a clathrate." Based on testing of tablets now in the US market, Bayer believes that Teva's Gianvi product does not in fact contain ethinyl estradiol stabilized by betadex as a clathrate.
Bayer intends to seek a temporary restraining order and a preliminary injunction to stop Teva from making false claims about its Gianvi product and from infringing Bayer Schering's U.S. Patent No. 5,798,338, which covers offers to sell a drug with an ethinyl estradiol that is stabilized by betadex as a clathrate. Bayer also asks that Teva take action in the US market to correct any erroneous impression persons may have derived concerning the nature, characteristics or qualities of Gianvi.
YAZ® (drospirenone & ethinyl estradiol) is indicated for:
- The prevention of pregnancy in women who elect to use an oral contraceptive.
- Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
- The effectiveness of YAZ® for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ® has not been evaluated for the treatment of premenstrual syndrome (PMS).
- Treatment of moderate acne vulgaris
- In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ® should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.
Important Safety Information About YAZ®
Who Shouldn't Take Any Oral Contraceptives (OCs)? Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
In Addition, Who Shouldn't Take YAZ®? YAZ® each contain drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ® if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ®.
What Drugs May Increase Potassium? NSAIDs-ibuprofen (Motrin®, Advil®), naproxen (Naprosyn®, Aleve®, and others) when taken long-term and daily for arthritis or other diseases or conditions, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.
What Are The Risks Involved With Taking Any Oral Contraceptive (OC)? OCs can be associated with an increased risk of several serious cardiovascular side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. OCs do not protect against HIV infection or other STDs.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ®, that were present in all YAZ® clinical trials included: upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, emotional lability, suspicious Papanicolaou smear, weight gain, depression, menstrual disorder, and asthenia.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ®, that were either unique to each trial type or occurred in only two types of clinical trials included:
In the contraception trial: leukorrhea, diarrhea, vomiting, vaginitis, flu syndrome, moniliasis, allergic reaction, cystitis, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.
In the PMDD trials: intermenstrual bleeding, decreased libido, nervousness, menorrhagia, pain in extremity, migraine, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, and acne.
In the acne trials: metrorrhagia, flu syndrome, menorrhagia, gastroenteritis, tooth disorder, infection, vomiting, pharyngitis, sore throat, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This release may contain forward-looking statements which are based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports which are available on our website. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.
SOURCE Bayer HealthCare Pharmaceuticals Inc.