Generic Vyalev Availability
Last updated on May 7, 2025.
Vyalev is a brand name of foscarbidopa/foslevodopa, approved by the FDA in the following formulation(s):
VYALEV (foscarbidopa; foslevodopa - solution;subcutaneous)
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Manufacturer: ABBVIE
Approval date: October 16, 2024
Strength(s): 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) [RLD]
Is there a generic version of Vyalev available?
No. There is currently no therapeutically equivalent version of Vyalev available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vyalev. 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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Carbidopa and L-dopa prodrugs and methods of use
Patent 10,174,061
Issued: January 8, 2019
Inventor(s): Cardinal-David; Benoit et al.
Assignee(s): ABBVIE INC. (North Chicago, IL)The present disclosure relates to (a) carbidopa prodrugs, (b) pharmaceutical combinations and compositions comprising a carbidopa prodrug and/or an L-dopa prodrug, and (c) methods of treating Parkinson's disease and associated conditions comprising administering a carbidopa prodrug and an L-dopa prodrug to a subject with Parkinson's disease.
Patent expiration dates:
- October 21, 2035✓✓
- October 21, 2035
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Carbidopa prodrug
Patent 10,730,895
Issued: August 4, 2020
Inventor(s): Kym; Philip R. et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)The present disclosure relates to (a) carbidopa prodrugs, (b) pharmaceutical combinations and compositions comprising a carbidopa prodrug and/or an L-dopa prodrug, and (c) methods of treating Parkinson's disease and associated conditions comprising administering a carbidopa prodrug and an L-dopa prodrug to a subject with Parkinson's disease.
Patent expiration dates:
- October 21, 2035✓
- October 21, 2035
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Pharmaceutical formulations for subcutaneous administration
Patent 12,251,365
Issued: March 18, 2025
Inventor(s): Moussa; Ehab et al.
Assignee(s): AbbVie Inc. (North Chicago, IL); AbbVie Deutschland Gmbh & Co. KG (Wiesbaden, DE)The present disclosure relates to compositions of levodopa 4′-monophosphate and carbidopa 4′-monophosphate having a weight by weight ratio of about 20:1 and methods of treating Parkinson's disease and associated conditions by subcutaneous administration of such compositions.
Patent expiration dates:
- June 11, 2040✓
- June 11, 2040
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Carbidopa and L-dopa prodrugs and methods of use
Patent 9,446,059
Issued: September 20, 2016
Inventor(s): Cardinal-David; Benoit et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)The present disclosure relates to (a) carbidopa prodrugs, (b) pharmaceutical combinations and compositions comprising a carbidopa prodrug and/or an L-dopa prodrug, and (c) methods of treating Parkinson's disease and associated conditions comprising administering a carbidopa prodrug and an L-dopa prodrug to a subject with Parkinson's disease.
Patent expiration dates:
- October 21, 2035✓✓✓
- October 21, 2035
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:
- October 16, 2027 - NEW PRODUCT
More about Vyalev (foscarbidopa / foslevodopa)
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- Drug class: dopaminergic antiparkinsonism agents
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.