Generic Ongentys Availability
Last updated on May 7, 2025.
Ongentys is a brand name of opicapone, approved by the FDA in the following formulation(s):
ONGENTYS (opicapone - capsule;oral)
Is there a generic version of Ongentys available?
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 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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Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof
Patent 10,071,085
Issued: September 11, 2018
Inventor(s): de Vasconcelos Teofilo Cardoso & dos Santos Lima Ricardo Jorge & de Campos Costa Rui Cerdeira
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✓
- March 31, 2030
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Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof
Patent 10,583,130
Issued: March 10, 2020
Inventor(s): de Vasconcelos Teofilo Cardoso & dos Santos Lima Ricardo Jorge & de Campos Costa Rui Cerdeira
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✓
- March 31, 2030
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Administration regime for nitrocatechols
Patent 12,129,247
Issued: October 29, 2024
Inventor(s): Soares Da Silva; Patricio Manuel Vieira Araujo et al.
Assignee(s): BIAL-PORTELA & CA, S.A. (S. Mamede Do Coronado, PT)A compound of formula (I) ##STR00001## where R.sub.1, R.sub.2, X, Y, n, m, R.sub.3, R.sub.4, R.sub.5, R.sub.6 and R.sub.7 are as defined herein, for use in the prophylaxis or treatment of a central and peripheral nervous system disorder, wherein the compound of formula (I) is administered prior to sleep, before bedtime or at bedtime.
Patent expiration dates:
- January 11, 2032✓
- January 11, 2032
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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✓✓✓
- April 2, 2029
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Dosage regimen for COMT inhibitors
Patent 8,524,746
Issued: September 3, 2013
Inventor(s): Learmonth David Alexander & Kiss Laszlo Erno & Palma Pedro Nuno Leal & Ferreira Humberto dos Santos & Silva Patricio Manuel Vieira Araujo Soares da
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✓
- July 14, 2029
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Nitrocatechol derivatives as COMT inhibitors
Patent 8,907,099
Issued: December 9, 2014
Inventor(s): Learmonth David Alexander & Kiss Laszlo Erno & Palma Pedro Nuno Leal & Ferreira Humberto Dos Santos & Soares da Silva Patricio Manuel Vieira Araújo
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✓
- May 12, 2027
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Nitrocatechol derivatives as COMT inhibitors
Patent 9,550,759
Issued: January 24, 2017
Inventor(s): Learmonth David Alexander & Kiss Laszlo Erno & Palma Pedro Nuno Leal & Ferreira Humberto Dos Santos & Soares Da Silva Patricio Manuel Vieira Araujo
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✓
- July 26, 2026✓
- July 26, 2026✓
- July 26, 2026
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Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor
Patent 9,630,955
Issued: April 25, 2017
Inventor(s): Russo; Domenico et al.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✓✓✓
- December 12, 2032
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Dosage regimen for COMT inhibitors
Patent 9,745,290
Issued: August 29, 2017
Inventor(s): Learmonth David Alexander & Kiss Laszlo Erno & Palma Pedro Nuno Leal & Ferreira Humberto dos Santos & Soares da Silva Patricio Manuel V. A.
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✓✓
- October 10, 2027
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
More about Ongentys (opicapone)
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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.
