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Last Updated: July 16, 2024

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ONGENTYS Drug Patent Profile


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Which patents cover Ongentys, and what generic alternatives are available?

Ongentys is a drug marketed by Amneal and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and twenty-three patent family members in thirty-one countries.

The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the opicapone profile page.

DrugPatentWatch® Generic Entry Outlook for Ongentys

Ongentys was eligible for patent challenges on April 24, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ONGENTYS
International Patents:123
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 4
Patent Applications: 75
Drug Prices: Drug price information for ONGENTYS
What excipients (inactive ingredients) are in ONGENTYS?ONGENTYS excipients list
DailyMed Link:ONGENTYS at DailyMed
Drug patent expirations by year for ONGENTYS
Drug Prices for ONGENTYS

See drug prices for ONGENTYS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ONGENTYS
Generic Entry Date for ONGENTYS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ONGENTYS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bial - Portela C S.A.Phase 1
Bial - Portela C S.A.Phase 4

See all ONGENTYS clinical trials

Pharmacology for ONGENTYS

US Patents and Regulatory Information for ONGENTYS

ONGENTYS is protected by ten US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ONGENTYS is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ONGENTYS

Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES

Dosage regimen for COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES BY INCREASING L-DOPA AMOUNTS THAT REACH THE BRAIN

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES BY INHIBITING COMT IN THE PERIPHERY

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES BY REDUCING O-METHYLATION OF L-DOPA

Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES

Dosage regimen for COMT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES

FDA Regulatory Exclusivity protecting ONGENTYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal ONGENTYS opicapone CAPSULE;ORAL 212489-001 Apr 24, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Amneal ONGENTYS opicapone CAPSULE;ORAL 212489-001 Apr 24, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Amneal ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ONGENTYS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bial - Portela Cª, S.A. Ongentys opicapone EMEA/H/C/002790
Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Authorised no no no 2016-06-24
Bial Portela & Companhia S.A. Ontilyv opicapone EMEA/H/C/005782
Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Authorised no no no 2022-02-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ONGENTYS

When does loss-of-exclusivity occur for ONGENTYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Patent: 2014014341
Patent: INTERMEDIÁRIO METILADO, SEU MÉTODO DE PREPARAÇÃO E SEUS USOS, E COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 58025
Patent: COMPOSE CHIMIQUE UTILE EN TANT QU'INTERMEDIAIRE POUR LA PREPARATION D'UN INHIBITEUR DE CATECHOL-O-METHYLTRANSFERASE (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING A CATECHOL-O-METHYLTRANSFERASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 88684
Patent: 5-[3-(2,5-DICHLORO-4,6-DIMETHYL-1-OXY-PYRIDIN-3-YL)- [1,2,4]OXADIAZOL-5YL]-2-HYDROXY-3-METHOXY-1-NITROBENZENE AS AN INTERMEDIATE TO PREPARE A CATECHOL-O-METHYLTRANSFERASE INHIBITOR
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0192133
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22580
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 91134
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 91134
Patent: COMPOSÉ CHIMIQUE UTILE EN TANT QU'INTERMÉDIAIRE POUR LA PRÉPARATION D'UN INHIBITEUR DE CATÉCHOL-O-MÉTHYLTRANSFÉRASE (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING A CATECHOL-O-METHYLTRANSFERASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 04299
Patent: COMPOSÉ CHIMIQUE UTILE EN TANT QU'INTERMÉDIAIRE POUR LA PRÉPARATION D'UN INHIBITEUR DE TRANSFÉRASE CATÉCHOL-0-MÉTHYLE (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING A CATECHOL-0-METHYL TRANSFERASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 47856
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 56143
Estimated Expiration: ⤷  Sign Up

Patent: 21558
Estimated Expiration: ⤷  Sign Up

Patent: 15500335
Patent: カテコール−O−メチル転移酵素阻害剤を調製するための中間体として有用な化学的化合物
Estimated Expiration: ⤷  Sign Up

Patent: 18052949
Patent: カテコール−O−メチル転移酵素阻害剤を調製するための中間体として有用な化学的化合物 (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING CATECHOL-O-METHYL TRANSFERASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 20059729
Patent: カテコール−O−メチル転移酵素阻害剤を調製するための中間体として有用な化学的化合物 (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING A CATECHOL-O-METHYLTRANSFERASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 91134
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 91134
Estimated Expiration: ⤷  Sign Up

Patent: 04299
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 666
Patent: HEMIJSKO JEDINJENJE KORISNO KAO INTERMEDIJER ZA PRIPREMU INHIBITORA KATEHOL-O-METILTRANSFERAZE (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING A CATECHOL-O-METHYLTRANSFERASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 91134
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 58659
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 1121413
Estimated Expiration: ⤷  Sign Up

Patent: 1201758
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ONGENTYS around the world.

Country Patent Number Title Estimated Expiration
Norway 341886 ⤷  Sign Up
Hungary E031317 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010114404 ⤷  Sign Up
Slovenia 1907382 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONGENTYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1907382 122016000095 Germany ⤷  Sign Up PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382 2016/054 Ireland ⤷  Sign Up PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382 SPC/GB16/065 United Kingdom ⤷  Sign Up CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONSAPPLICANT: BIAL-PORTELA & CA, S.A.A AVENIDA DA SIDERURGIA, NACIONAL, 4745-457 S.MAMEDE DO CORONADO, PORTUGALPRODUCT: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREO FPRODUCT TYPE: MEDICINAL AUTHORISED: UK EU/1/15/1066/001/010 28 JUNE 2016 AUTHORISED EXTENSION: PATENT NO: EP1907382 TITLE: NITROCATECHOL DERIVATIVES AS COMT INHIBITORS SPC NO: SPC/GB16/065DATE GRANTED: 20 NOVEMBER 2020 MAXIMUM PERIOD EXPIRES ON: 27 JUNE 2031*CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6865 DATED 16 DECEMBER 2020 TO INCLUDE MAXIMUM EXPIRY DETAILS AND UPDATED AUTHORISATION DETAILS.
1907382 16C1016 France ⤷  Sign Up PRODUCT NAME: OPICAPONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/1066 20160628
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.