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Last Updated: May 20, 2022

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:127
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 4
Patent Applications: 108
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 Generic Entry Opportunity 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

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicaments for slowing Parkinson's disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Nitrocatechol derivatives as COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Dosage regimen for COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Nitrocatechol derivatives as COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nitrocatechol derivatives as COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING COMT IN THE PERIPHERY

Nitrocatechol derivatives as COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Nitrocatechol derivatives as COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF REDUCING O-METHYLATION OF L-DOPA

Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

Dosage regimen for COMT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PARKINSON'S DISEASE

FDA Regulatory Exclusivity protecting ONGENTYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

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: See Plans and Pricing

Patent: 88684
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0192133
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 91134
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 91134
Estimated Expiration: See Plans and Pricing

Patent: 04299
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 47856
Estimated Expiration: See Plans and Pricing

Japan

Patent: 56143
Estimated Expiration: See Plans and Pricing

Patent: 21558
Estimated Expiration: See Plans and Pricing

Patent: 15500335
Estimated Expiration: See Plans and Pricing

Patent: 18052949
Estimated Expiration: See Plans and Pricing

Patent: 20059729
Estimated Expiration: See Plans and Pricing

Poland

Patent: 91134
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 91134
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 666
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 91134
Estimated Expiration: See Plans and Pricing

Spain

Patent: 58659
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 1121413
Estimated Expiration: See Plans and Pricing

Patent: 1201758
Estimated Expiration: See Plans and Pricing

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
China 102448444 Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof See Plans and Pricing
Japan 6456143 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010114404 See Plans and Pricing
Japan 2016020366 COMT阻害剤 (COMT INHIBITORS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2016083875 See Plans and Pricing
Hungary S1600056 See Plans and Pricing
Hong Kong 1120266 NITROCATECHOL DERIVATIVES AS COMT INHIBITORS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONGENTYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1907382 16C1016 France See Plans and Pricing PRODUCT NAME: OPICAPONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/1066 20160628
1907382 57/2016 Austria See Plans and Pricing PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 (MITTEILUNG) 20160628
1907382 132016000123029 Italy See Plans and Pricing PRODUCT NAME: OPICAPONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ONGENTYS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1066, 20160628
1907382 PA2016036,C1907382 Lithuania See Plans and Pricing PRODUCT NAME: OPIKAPONAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382 C01907382/01 Switzerland See Plans and Pricing PRODUCT NAME: OPICAPON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66547 26.04.2018
1907382 271 50011-2016 Slovakia See Plans and Pricing PRODUCT NAME: OPIKAPON VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1066/001 - EU/1/15/1066/010 20160628
1907382 CA 2016 00061 Denmark See Plans and Pricing PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.