Generic Safyral Availability

Safyral is a brand name of drospirenone/ethinyl estradiol/levomefolate calcium, approved by the FDA in the following formulation(s):

SAFYRAL (drospirenone; ethinyl estradiol; levomefolate calcium - tablet;oral)

  • Manufacturer: BAYER HLTHCARE
    Approval date: December 16, 2010
    Strength(s): 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

Has a generic version of Safyral been approved?

No. There is currently no therapeutically equivalent version of Safyral available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Safyral. 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
  • Stable crystalline salts of 5-methyltetrahydrofolic acid
    Patent 6,441,168
    Issued: August 27, 2002
    Inventor(s): Rudolf; Müller & Rudolf; Moser & Thomas; Egger
    Assignee(s): Eprova AG
    This invention relates to stable crystalline salts of 5-methyl-(6R,S)-, -(6S)- and -(6R)-tetrahydrofolic acid, to methods of producing these salts and to the use thereof use as a constituent for the production of drugs or as a food additive, and to preparations containing these salts.
    Patent expiration dates:
    • April 17, 2020
      ✓ 
      Drug substance
  • 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
  • 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:
    • March 3, 2022
      ✓ 
      Patent use: PREVENTION OF PREGNANCY
  • Pharmaceutical composition containing a tetrahydrofolic acid
    Patent 8,617,597
    Issued: December 31, 2013
    Assignee(s): Bayer Intellectual Property GmbH
    The present invention relates to solid pharmaceutical compositions, in particular to oral contraceptives, comprising a progestogen, such as drospirenone; an estrogen, such as ethinylestradiol; a tetrahydrofolic acid or a pharmaceutically acceptable salt thereof, such as calcium 5-methyl-(6S)-tetrahydrofolate; and at least one pharmaceutical acceptable excipient or carrier. The compositions of the invention provide good stability of the tetrahydrofolic acid upon storage while still ensuring a fast and reliable release of the estrogen and the progestogen present in the composition.
    Patent expiration dates:
    • February 8, 2030
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • December 16, 2013 -

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.
Hide
(web4)