Although the first patent for Yaz doesn't expire until June 2014, there are already generic versions of the birth control pill. They are marketed under the names Gianvi, Loryna, and Vestura. The makers of Yaz have filed a lawsuit to keep Gianvi from being sold, as the generic was introduced to the market earlier than the agreed-upon date.
Generic Yaz: An Overview
Yaz® (drospirenone/ethinyl estradiol) is a prescription contraceptive product. It is one of the many oral contraceptives (birth control pills) available. In addition to preventing pregnancy, Yaz is approved to treat acne and premenstrual dysphoric disorder (PMDD).
Yaz is made by Bayer HealthCare Pharmaceuticals. At this time, there are two generic versions of Yaz.
Patent Issues Surrounding Generic Yaz
The first patent for Yaz currently expires in June 2014. However, Barr Pharmaceuticals (a major generic drug manufacturer) and the makers of Yaz had entered into a settlement in which Barr would be allowed to market a generic version of Yaz no later than July 2011. Barr has since been bought out by Teva Specialty Pharmaceuticals.
Quite surprisingly, Teva began selling its generic version of Yaz (under the name Gianvi™) in June 2010, much earlier than the agreed-upon date. Bayer HealthCare Pharmaceuticals immediately filed a lawsuit (as would be expected). It is possible that Gianvi will be removed from the market if Teva loses the lawsuit.
In April 2011, another generic version of Yaz, which will be marketed under the name Loryna™, was also approved. In November 2011, a third generic version of Yaz, sold under the name Vestura™, was also approved.
Are the Generic Versions as Good as Yaz?
All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns a rating to each one.
An "AB" rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. Vestura, Gianvi, and Loryna each have an "AB" rating, meaning they should be equivalent to Yaz.
However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Yaz [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, Inc.;2007 February.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed February 9, 2012.
Barr Pharmaceuticals. Barr and Bayer sign supply and licensing agreements for launch of generic Yasmin(R) and Yaz(R) oral contraceptives (6/24/2008). Barr Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=60908&p=irol-newsArticle&ID=1168797&highlight=. Accessed September 19, 2008.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click