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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)

  • 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)

  • 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: JAI PHARMA 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]

LORYNA (drospirenone; ethinyl estradiol tablet;oral)

  • Manufacturer: SANDOZ
    Approval date: March 28, 2011
    Strength(s): 3MG;0.02MG [AB]

MELAMISA (drospirenone; ethinyl estradiol tablet;oral)

  • Manufacturer: NOVAST LABS LTD
    Approval date: January 26, 2016
    Strength(s): 3MG;0.02MG [AB]

NIKKI (drospirenone; ethinyl estradiol tablet;oral)

  • 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: About generic drugs.

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.

  • Solid dosage forms that contain clathrates of 17.alpha.-ethinyl estradiol
    Patent 5,798,338
    Issued: August 25, 1998
    Inventor(s): Backensfeld; Thomas & Tack; Johannes
    Assignee(s): Schering Aktiengesellschaft
    A method and pharmaceutical compositions are disclosed for reducing oxidative degradation of 17 .alpha.-ethinylestradiol comprising combining the estradiol with an effective amount of cyclodextrin, thus forming a cyclodextrin clathrate of the steroid.
    Patent expiration dates:
    • July 10, 2015
      ✓ 
      Drug product
  • Pharmaceutical composition for use as a contraceptive
    Patent 6,787,531
    Issued: September 7, 2004
    Inventor(s): Juergen; Hilman & Wolfgang; Heil & Ralph; Lipp & Renate; Heithecker & Michael; Huempel & Johannes W.; Tack
    Assignee(s): Schering AG
    A pharmaceutical composition comprises, as a first active agent, 6&bgr;,7&bgr;;15&bgr;,16&bgr;-dimethylene-3-oxo-17&agr;-pregn-4-ene-21,17-carbolactone (drospirenone) in an amount corresponding to a daily dosage, on administration of the composition, of from about 2 mg to about 4 mg, and, as a second active agent, 17&agr;-ethinylestradiol (ethinylestradiol) in an amount corresponding to a daily dosage of from about 0.01 mg to about 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients. In a specific embodiment, the composition consists of a number of separately packaged and individually removable daily dosage units placed in a packaging unit and intended for oral administration for a period of at least 21 consecutive days, wherein said daily dosage units comprises the combination of drospirenone and ethinylestradiol. The composition may further comprise 7 or less daily dosage units containing no active agent or containing ethinylestradiol alone.
    Patent expiration dates:
    • August 31, 2020
      ✓ 
      Drug product
  • PROCESSING FOR PRODUCING OF DROSPIRENONE (6β, 7β, 15β, 16β-DIMETHYLENE-3-OXO-17α-PREGN-4-EN-21, 17-CARBOLACTONE, DRSP) AS WELL AS 7α-(3-HYDOXY-1-PROPLY)-6β, 7β; 15β, 16β-DIMETHYLENE-5β-ANDR
    Patent 6,933,395
    Issued: August 23, 2005
    Inventor(s): Mohr; Jörg-Thorsten & Nickisch; Klaus
    Assignee(s): Schering AG
    Process for the production of drospirenone (6β,7β; 15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone, DRSP) (1) and 7α-(3-hydroxy-1-propyl)-6β,7β; 15β,16β-dimethylene-5β-androstane-3β,5,17β-triol (ZK 92836) and 6β,7β; 15β,16β-dimethylene-5β-hydroxy-3-oxo-17α-androstane-21,17-carbolactone (ZK 90965) as intermediate products of the process.
    Patent expiration dates:
    • August 11, 2017
      ✓ 
      Drug product
  • Cyclodextrin-drospirenone inclusion complexes
    Patent 6,958,326
    Issued: October 25, 2005
    Inventor(s): Backensfeld; Thomas & Heil; Wolfgang & Lipp; Ralph
    Assignee(s): Schering AG
    Pharmaceutical 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
      ✓ 
      Drug product
  • Therapeutic gestagens for the treatment of premenstrual dysphoric disorder
    Patent 6,987,101
    Issued: January 17, 2006
    Inventor(s): Nashed; Norman
    Assignee(s): Schering Aktiengesellschaft
    A method for treating premenstrual dysphoric disorder comprises administering a therapeutically effective amount of a gestagen. Optionally, a natural or synthetic estrogen is also administered. In one embodiment, the gestagen and optional estrogen are administered during the luteal phase of the female menstrual cycle, preferably from day 10 to day 28.
    Patent expiration dates:
    • December 22, 2017
      ✓ 
      Patent use: TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER
  • Compositions of estrogen-cyclodextrin complexes
    Patent 7,163,931
    Issued: January 16, 2007
    Inventor(s): Backensfeld; Thomas & Heil; Wolfgang & Lipp; Ralph
    Assignee(s): Schering Aktiengesellchaft
    Pharmaceutical 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
      ✓ 
      Patent use: PREVENTION OF PREGNANCY
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Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts 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.

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