Generic Nucynta Availability
Last updated on Apr 10, 2025.
See also: Generic Nucynta ER
Nucynta is a brand name of tapentadol, approved by the FDA in the following formulation(s):
NUCYNTA (tapentadol hydrochloride - solution;oral)
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Manufacturer: COLLEGIUM PHARM INC
Approval date: October 15, 2012
Strength(s): EQ 20MG BASE/ML (discontinued) [RLD]
NUCYNTA (tapentadol hydrochloride - tablet;oral)
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Manufacturer: COLLEGIUM PHARM INC
Approval date: November 20, 2008
Strength(s): EQ 50MG BASE [RLD], EQ 75MG BASE [RLD], EQ 100MG BASE [RLD]
Is there a generic version of Nucynta available?
No. There is currently no therapeutically equivalent version of Nucynta available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nucynta. 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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Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent 7,994,364
Issued: August 9, 2011
Inventor(s): Fischer; Andreas et al.
Assignee(s): Gruenenthal GmbH (Aachen, DE)A hitherto unknown crystalline form of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride, pharmaceutical compositions containing the new crystalline form, methods of producing the new crystalline form, and a related method of use including treatment of, e.g., pain and/or urinary incontinence.
Patent expiration dates:
- June 27, 2025✓✓✓
- June 27, 2025✓✓✓
- June 27, 2025
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Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent 7994364*PED
Issued: August 9, 2011
Inventor(s): Fischer; Andreas et al.
Assignee(s): Gruenenthal GmbH (Aachen, DE)A hitherto unknown crystalline form of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride, pharmaceutical compositions containing the new crystalline form, methods of producing the new crystalline form, and a related method of use including treatment of, e.g., pain and/or urinary incontinence.
Patent expiration dates:
- December 27, 2025✓
- December 27, 2025
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:
- July 3, 2026 - NEW PATIENT POPULATION
- January 3, 2027 - PEDIATRIC EXCLUSIVITY
More about Nucynta (tapentadol)
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- Drug class: Opioids (narcotic analgesics)
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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.
