Safyral

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.

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
  
  

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 - NEW PRODUCT
  
  

See also...

• Safyral Consumer Information (Drugs.com)
• Safyral Consumer Information (Wolters Kluwer)
• Safyral Consumer Information (Cerner Multum)
• Safyral Advanced Consumer Information (Micromedex)
• Drospirenone/Ethinyl Estradiol/Levomefolate Consumer Information (Wolters Kluwer)
• Drospirenone, ethinyl estradiol, and levomefolate Consumer Information (Cerner Multum)
• Drospirenone, ethinyl estradiol, and levomefolate Advanced Consumer Information (Micromedex)