Generic Lyvispah Availability
Last updated on May 7, 2025.
Lyvispah is a brand name of baclofen, approved by the FDA in the following formulation(s):
LYVISPAH (baclofen - granules;oral)
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Manufacturer: AMNEAL
Approval date: November 22, 2021
Strength(s): 5MG/PACKET [RLD], 10MG/PACKET [RLD], 20MG/PACKET [RLD]
Is there a generic version of Lyvispah available?
No. There is currently no therapeutically equivalent version of Lyvispah available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lyvispah. 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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Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Patent 10,792,262
Issued: October 6, 2020
Inventor(s): Penake David & Hamm Sharon & "OMahony Leonard" & Devane John & Mohr Wolfgang & Weinheimer Manuel
Assignee(s): SAOL INTERNATIONAL LIMITEDPharmaceutical compositions including an active ingredient and a stabilizer, as well as methods of manufacture of the compositions, and methods of their use.
Patent expiration dates:
- July 29, 2039✓✓
- July 29, 2039
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Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Patent 11,491,125
Issued: November 8, 2022
Inventor(s): O'Mahony; Leonard et al.
Assignee(s): AMNEAL PHARMACEUTICALS LLC (Bridgewater, NJ)Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure to baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.
Patent expiration dates:
- September 29, 2041✓✓
- September 29, 2041✓✓
- September 29, 2041
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Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Patent 11,654,124
Issued: May 23, 2023
Inventor(s): Penake; David et al.
Assignee(s): AMNEAL PHARMACEUTICALS LLC (Bridgewater, NJ)Pharmaceutical compositions including an active ingredient and a stabilizer, as well as methods of manufacture of the compositions, and methods of their use. The composition may include the active ingredient dispersed throughout a matrix of the stabilizer. In some embodiments, the active ingredient and the stabilizer are intimately mixed in a matrix formulation. In some embodiments, the active ingredient is selected from 4 amino-3-(4-chlorophenyl)butanoic acid) (“baclofen”) and its pharmaceutically acceptable salts.
Patent expiration dates:
- July 29, 2039✓
- July 29, 2039
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Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Patent 11,850,225
Issued: December 26, 2023
Inventor(s): O'Mahony; Leonard et al.
Assignee(s): AMNEAL PHARMACEUTICALS LLC (Bridgewater, NJ)Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.
Patent expiration dates:
- September 29, 2041✓✓
- September 29, 2041✓✓
- September 29, 2041
-
Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Patent 11,931,328
Issued: March 19, 2024
Inventor(s): Penake; David et al.
Assignee(s): AMNEAL PHARMACEUTICALS LLC (Bridgewater, NJ)Pharmaceutical compositions including an active ingredient and a stabilizer, as well as methods of manufacture of the compositions, and methods of their use. The composition may include the active ingredient dispersed throughout a matrix of the stabilizer. In some embodiments, the active ingredient and the stabilizer are intimately mixed in a matrix formulation. In some embodiments, the active ingredient is selected from 4 amino-3-(4-chlorophenyl)butanoic acid) (“baclofen”) and its pharmaceutically acceptable salts.
Patent expiration dates:
- July 29, 2039✓
- July 29, 2039
More about Lyvispah (baclofen)
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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
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