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Last Updated: June 4, 2023

ONGENTYS Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Ongentys

Ongentys will be eligible for patent challenges on April 24, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:128
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 4
Patent Applications: 130
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
Anatomical Therapeutic Chemical (ATC) Classes for ONGENTYS

US Patents and Regulatory Information for ONGENTYS

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

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicaments for slowing Parkinson's disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE

Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Dosage regimen for COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF INHIBITING COMT IN THE PERIPHERY

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Nitrocatechol derivatives as COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF REDUCING O-METHYLATION OF L-DOPA

Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Dosage regimen for COMT inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

FDA Regulatory Exclusivity protecting ONGENTYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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

Canada

Patent: 58025
Estimated Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

Croatia

Patent: 0192133
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 22580
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 91134
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 91134
Estimated Expiration: ⤷  Try a Trial

Patent: 04299
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 47856
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 56143
Estimated Expiration: ⤷  Try a Trial

Patent: 21558
Estimated Expiration: ⤷  Try a Trial

Patent: 15500335
Estimated Expiration: ⤷  Try a Trial

Patent: 18052949
Estimated Expiration: ⤷  Try a Trial

Patent: 20059729
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 91134
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 91134
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 666
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 91134
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 58659
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 1121413
Estimated Expiration: ⤷  Try a Trial

Patent: 1201758
Estimated Expiration: ⤷  Try a Trial

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
Japan 2018500300 パーキンソン病を遅延させるための医薬 ⤷  Try a Trial
Canada 2678391 SCHEMA POSOLOGIQUE POUR DES INHIBITEURS DE LA CATECHOL-O-METHYLTRANSFERASE (DOSAGE REGIMEN FOR COMT INHIBITORS) ⤷  Try a Trial
Japan 2020059729 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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONGENTYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1907382 CR 2016 00061 Denmark ⤷  Try a Trial PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382 93327 Luxembourg ⤷  Try a Trial PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE
1907382 PA2016036 Lithuania ⤷  Try a Trial PRODUCT NAME: OPIKAPONAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Boehringer Ingelheim
Express Scripts
Dow
Mallinckrodt

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.