Navigation Links
Bayer Sues Teva and Barr for False Advertising and Patent Infringement in Connection with Teva's Generic Oral Contraceptive Gianvi™
Date:6/15/2010

WAYNE, N.J., June 15 /PRNewswire/ -- Today, Bayer HealthCare Pharmaceuticals Inc. and Bayer Schering Pharma AG sued Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, and Barr Laboratories, Inc. in the Northern District of Illinois (Chicago) for false advertising and patent infringement in connection with Teva's generic oral contraceptive, Gianvi™.  Teva's product is sold as a generic version of Bayer HealthCare's leading oral contraceptive YAZ®.  

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™.

About YAZ®

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.

Forward-Looking Statement

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 conform them to future events or developments.


'/>"/>
SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Bayer HealthCare Pharmaceuticals, Inc. Announces Results of a Phase 3 Clinical Trial of Gadobutrol
2. Bayer Diabetes Care Introduces DIDGET In the US
3. FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
4. Bayers A1CNow(R) SELFCHECK At-Home A1C System Now Available In Local Pharmacies
5. VisEn Acquires Key Fluorescence Agent Intellectual Property Portfolio and Technology Platforms From Bayer Schering Pharma
6. Bayer Consumer Care Voluntarily Recalls One Lot of Combination Package of Alka-Seltzer Plus(R) Day & Night Cold Formula Liquid Gels
7. Bayer Express Your Simple Win Creativity Contest Grand Prize Winners Announced
8. Bayer Schering Exercises Option to Develop Solid Tumor BiTE Antibody with Micromet
9. Simmons Firms Partner Trent Miracle Chosen to Help Lead National Litigation Against Bayer
10. Bayer HealthCare Pharmaceuticals Initiates Phase III Trial with Florbetaben PET Tracer for Imaging of Cerebral beta-Amyloid Plaques, a Pathological Hallmark of Alzheimers Disease
11. Bayer Consumer Care Launches Citracal(R) Calcium Plus Heart Health, First-Ever Leading Calcium Supplement to Help Support Bone AND Heart Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... , Schweiz, April 27, 2016 ... Sachs CEO Forums in Zürich gab Strekin ... führenden Wirkstoffkandidaten STR001 zur Erhaltung des Resthörvermögens ... wurde, bekannt. Für die umfassende Phase-II-Doppelblindstudie mit ... Frankreich angeworben. STR001 wird während der Operation ...
(Date:4/27/2016)... 27, 2016   Zillion Group today ... technology platform, which specializes in live video consultation. ... digital products, Zillion enables companies to realize the ... to take control of their health. ... – including one-to-one, group and webcast scheduled or ...
(Date:4/27/2016)... NEW YORK , April 27, 2016 /PRNewswire/ ... OASM ), a developer of a new ... today announced positive overall survival results for Paclical/Apealea ... total of 789 patients with epithelial ovarian cancer. ... treatment groups: Paclical/Apealea in combination with carboplatin versus ...
Breaking Medicine Technology:
(Date:4/30/2016)... (PRWEB) , ... April 30, 2016 , ... ... Dr. Carol Francis Talk Radio with Hypnotherapist, Mary O'Maley. What is hypnosis ... with habit control (substances, smoking, weight control), pain relief (chronic and acute), birthing ...
(Date:4/30/2016)... ... April 30, 2016 , ... ... News on April 4th, 2016 questioned the use of the HyProCure sinus ... as “a controversial procedure.” EOTTS-HyProCure is a minimally invasive procedure performed, when ...
(Date:4/29/2016)... ... 2016 , ... Mercy College is expanding its Graduate Business Programs to the ... due to high demand: Master of Business Administration (MBA), Master of Organizational Leadership (MSOL) ... , School of Business Graduate Program Chair Dr. Ray Manganelli said: “We believe that ...
(Date:4/29/2016)... ... April 29, 2016 , ... Shamangelic ... the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula for brain ... mood optimization products to the store is just one more way Shamangelic Healing ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... ... advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and MIRACLES") ... Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie Siegel, ...
Breaking Medicine News(10 mins):