Generic Beyaz Availability
Last updated on Sep 11, 2024.
Beyaz is a brand name of drospirenone/ethinyl estradiol/levomefolate calcium, approved by the FDA in the following formulation(s):
BEYAZ (drospirenone; ethinyl estradiol; levomefolate calcium - tablet;oral)
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Manufacturer: BAYER HLTHCARE
Approval date: September 24, 2010
Strength(s): 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG [RLD] [AB]
Has a generic version of Beyaz been approved?
A generic version of Beyaz 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 Beyaz and have been approved by the FDA:
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (drospirenone; ethinyl estradiol; levomefolate calcium tablet;oral)
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Manufacturer: LUPIN LTD
Approval date: June 13, 2018
Strength(s): 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG [AB] -
Manufacturer: WATSON LABS INC
Approval date: October 11, 2016
Strength(s): 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Beyaz. 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 FAQ.
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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Patent 11,617,751
Patent expiration dates:
- July 17, 2030✓✓
- July 17, 2030✓✓
- July 17, 2030✓✓
- July 17, 2030✓✓
- July 17, 2030
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Pharmaceutical composition containing a tetrahydrofolic acid
Patent 8,617,597
Issued: December 31, 2013
Inventor(s): King Kristina
Assignee(s): Bayer Intellectual Property GmbHThe 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✓
- February 8, 2030
More about Beyaz (drospirenone / ethinyl estradiol / levomefolate calcium)
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- Drug class: contraceptives
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Glossary
Term | Definition |
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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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.