Generic Yaz Availability
Yaz is a brand name of drospirenone/ethinyl estradiol, approved by the FDA in the following formulation(s):
YAZ (drospirenone; ethinyl estradiol - tablet;oral)
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Manufacturer: BAYER HLTHCARE
Approval date: March 16, 2006
Strength(s): 3MG;0.02MG [RLD] [AB]
Has a generic version of Yaz been approved?
A generic version of Yaz has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Yaz and have been approved by the FDA:
DROSPIRENONE AND ETHINYL ESTRADIOL (drospirenone; ethinyl estradiol tablet;oral)
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Manufacturer: ALLIED
Approval date: July 18, 2017
Strength(s): 3MG;0.02MG [AB] -
Manufacturer: BARR
Approval date: March 30, 2009
Strength(s): 3MG;0.02MG [AB] -
Manufacturer: GLENMARK PHARMS LTD
Approval date: August 17, 2015
Strength(s): 3MG;0.02MG [AB] -
Manufacturer: HETERO LABS LTD
Approval date: March 22, 2019
Strength(s): 3MG;0.02MG [AB] -
Manufacturer: JUBILANT CADISTA
Approval date: December 22, 2017
Strength(s): 3MG;0.02MG [AB] -
Manufacturer: MYLAN LABS LTD
Approval date: October 22, 2015
Strength(s): 3MG;0.02MG [AB] -
Manufacturer: WATSON LABS
Approval date: November 28, 2011
Strength(s): 3MG;0.02MG [AB]
KYRA (drospirenone; ethinyl estradiol tablet;oral)
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Manufacturer: SUN PHARM
Approval date: July 23, 2019
Strength(s): 3MG;0.02MG [AB]
LO-ZUMANDIMINE (drospirenone; ethinyl estradiol tablet;oral)
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Manufacturer: AUROBINDO PHARMA LTD
Approval date: February 27, 2018
Strength(s): 3MG;0.02MG [AB]
LORYNA (drospirenone; ethinyl estradiol tablet;oral)
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Manufacturer: XIROMED
Approval date: March 28, 2011
Strength(s): 3MG;0.02MG [AB]
MELAMISA (drospirenone; ethinyl estradiol tablet;oral)
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Manufacturer: NOVAST LABS
Approval date: January 26, 2016
Strength(s): 3MG;0.02MG [AB]
NIKKI (drospirenone; ethinyl estradiol tablet;oral)
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Manufacturer: LUPIN LTD
Approval date: May 27, 2014
Strength(s): 3MG;0.02MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Yaz. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Cyclodextrin-drospirenone inclusion complexes
Patent 6,958,326
Issued: October 25, 2005
Inventor(s): Backensfeld; Thomas & Heil; Wolfgang & Lipp; Ralph
Assignee(s): Schering AGPharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and β-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.
Patent expiration dates:
- December 20, 2021✓
- December 20, 2021
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Compositions of estrogen-cyclodextrin complexes
Patent 7,163,931
Issued: January 16, 2007
Inventor(s): Backensfeld; Thomas & Heil; Wolfgang & Lipp; Ralph
Assignee(s): Schering AktiengesellchaftPharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and β-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.
Patent expiration dates:
- December 20, 2021✓
- December 20, 2021
More about Yaz (drospirenone / ethinyl estradiol)
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- 751 Reviews
- Drug class: contraceptives
- FDA Alerts (5)
- FDA Approval History
Consumer resources
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.