ONGENTYS Drug Patent Profile
✉ Email this page to a colleague
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 nine patents protecting this drug.
This drug has one hundred and fifty patent family members in thirty-one countries.
The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this compound. One supplier is 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ONGENTYS?
- What are the global sales for ONGENTYS?
- What is Average Wholesale Price for ONGENTYS?
Summary for ONGENTYS
International Patents: | 150 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 4 |
Patent Applications: | 81 |
Drug Prices: | Drug price information for ONGENTYS |
What excipients (inactive ingredients) are in ONGENTYS? | ONGENTYS excipients list |
DailyMed Link: | ONGENTYS at DailyMed |


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
Sponsor | Phase |
---|---|
Bial - Portela C S.A. | Phase 1 |
Bial - Portela C S.A. | Phase 4 |
Pharmacology for ONGENTYS
Drug Class | Catechol-O-Methyltransferase Inhibitor |
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
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 for Free.
This potential generic entry date is based on patent 9,630,955.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 9,745,290 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Amneal | ONGENTYS | opicapone | CAPSULE;ORAL | 212489-002 | Apr 24, 2020 | RX | Yes | Yes | 8,524,746 | ⤷ Try for Free | ⤷ Try for Free | ||||
Amneal | ONGENTYS | opicapone | CAPSULE;ORAL | 212489-002 | Apr 24, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Amneal | ONGENTYS | opicapone | CAPSULE;ORAL | 212489-001 | Apr 24, 2020 | RX | Yes | No | 8,168,793 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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: ⤷ Try for Free
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: ⤷ Try for Free
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 for Free
Croatia
Patent: 0192133
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 22580
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 91134
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Hungary
Patent: 47856
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 56143
Estimated Expiration: ⤷ Try for Free
Patent: 21558
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Poland
Patent: 91134
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 91134
Estimated Expiration: ⤷ Try for Free
Patent: 04299
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Slovenia
Patent: 91134
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 58659
Estimated Expiration: ⤷ Try for Free
United Kingdom
Patent: 1121413
Estimated Expiration: ⤷ Try for Free
Patent: 1201758
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
European Patent Office | 2124947 | SCHÉMA POSOLOGIQUE POUR DES INHIBITEURS DE LA CATÉCHOL-O-MÉTHYLTRANSFÉRASE (DOSAGE REGIMEN FOR COMT INHIBITORS) | ⤷ Try for Free |
European Patent Office | 2413912 | PRÉPARATIONS PHARMACEUTIQUES COMPRENANT DES DÉRIVÉS DE NITROCATÉCHOL ET LEURS PROCÉDÉS DE FABRICATION (PHARMACEUTICAL FORMULATIONS COMPRISING NITROCATECHOL DERIVATIVES AND METHODS OF MAKING THEREOF) | ⤷ Try for Free |
Hong Kong | 1120266 | NITROCATECHOL DERIVATIVES AS COMT INHIBITORS | ⤷ Try for Free |
Slovenia | 2672973 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ONGENTYS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1907382 | 2016/054 | Ireland | ⤷ Try for Free | PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1066 20160624 |
1907382 | 93327 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE |
1907382 | 271 50011-2016 | Slovakia | ⤷ Try for Free | 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 | 300848 | Netherlands | ⤷ Try for Free | PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for ONGENTYS
More… ↓