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Generic Ongentys Availability

Ongentys is a brand name of opicapone, approved by the FDA in the following formulation(s):

ONGENTYS (opicapone - capsule;oral)

  • Manufacturer: NEUROCRINE
    Approval date: April 24, 2020
    Strength(s): 25MG [RLD], 50MG [RLD]

Has a generic version of Ongentys been approved?

No. There is currently no therapeutically equivalent version of Ongentys available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ongentys. 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 FAQs.

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.

  • Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof
    Patent 10,071,085
    Issued: September 11, 2018
    Assignee(s): BIAL—Portela & CA, S.A.

    The present disclosure relates to compositions and pharmaceutical formulations comprising at least one active pharmaceutical ingredient chosen from nitrocatechol derivatives of formula I as defined herein and salts, esters, hydrates, solvates and derivatives thereof and methods of making said compositions and pharmaceutical formulations.

    Patent expiration dates:

    • March 31, 2030
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      Drug product
  • Patent 10,357,468

    Patent expiration dates:

    • May 27, 2035
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      Patent use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE
  • Patent 10,583,130

    Patent expiration dates:

    • March 31, 2030
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      Patent use: METHOD OF TREATING PARKINSON'S DISEASE
  • Nitrocatechol derivatives as COMT inhibitors
    Patent 8,168,793
    Issued: May 1, 2012
    Inventor(s): Learmonth; David Alexander & Kiss; Laszlo Erno & Palma; Pedro Nuno Leal & Ferreira; Humberto Dos Santos & da Silva; Patricio Manuel Vieira Araújo Soares
    Assignee(s): Portela & CA., S.A.

    New compounds of formula I are described. The compounds have potentially valuable pharmaceutical properties in the treatment of some central and peripheral nervous system disorders.

    Patent expiration dates:

    • April 2, 2029
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      Patent use: METHOD OF TREATING PARKINSON'S DISEASE
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      Drug substance
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      Drug product
  • Dosage regimen for COMT inhibitors
    Patent 8,524,746
    Issued: September 3, 2013
    Assignee(s): Bial-Portela & Ca., S.A.

    The invention relates to the use of an oxodiazolyl compound (I) for the preparation of a medicament for the prevention or treatment of central and peripheral nervous system associated disorders, wherein said medicament is administered according to a dosing regimen having a dosing periodicity ranging from about twice a day to about once every other day.

    Patent expiration dates:

    • July 14, 2029
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      Patent use: METHOD OF TREATING PARKINSON'S DISEASE
  • Nitrocatechol derivatives as COMT inhibitors
    Patent 8,907,099
    Issued: December 9, 2014
    Assignee(s): Bial-Portela & Ca, S.A.

    New compounds of formula I are described. The compounds have potentially valuable pharmaceutical properties in the treatment of some central and peripheral nervous system disorders.

    Patent expiration dates:

    • May 12, 2027
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      Drug substance
  • Nitrocatechol derivatives as COMT inhibitors
    Patent 9,550,759
    Issued: January 24, 2017
    Assignee(s): BIAL—PORTELA & CA, S.A.

    New compounds of formula I are described. The compounds have potentially valuable pharmaceutical properties in the treatment of some central and peripheral nervous system disorders.

    Patent expiration dates:

    • July 26, 2026
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      Patent use: METHOD OF INHIBITING COMT IN THE PERIPHERY
    • July 26, 2026
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      Patent use: METHOD OF TREATING PARKINSON'S DISEASE
    • July 26, 2026
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      Patent use: METHOD OF REDUCING O-METHYLATION OF L-DOPA
  • Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor
    Patent 9,630,955
    Issued: April 25, 2017

    There is disclosed a methylated intermediate which may be demethylated to provide an inhibitor of catechol-O-methyltransferase useful in the treatment of Parkinson's disease. Also disclosed are methods of making and using said intermediate.

    Patent expiration dates:

    • December 12, 2032
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      Patent use: METHOD OF TREATING PARKINSON'S DISEASE
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      Drug substance
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      Drug product
  • Dosage regimen for COMT inhibitors
    Patent 9,745,290
    Issued: August 29, 2017
    Assignee(s): BIAL—PORTELA & CA, S.A.

    The invention relates to the use of an oxodiazolyl compound (I) for the preparation of a medicament for the prevention or treatment of central and peripheral nervous system associated disorders, wherein said medicament is administered according to a dosing regimen having a dosing periodicity ranging from about twice a day to about once every other day.

    Patent expiration dates:

    • October 10, 2027
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      Patent use: METHOD OF TREATING PARKINSON'S DISEASE
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      Drug product

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:

    • April 24, 2025 - NEW CHEMICAL ENTITY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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.