ONGENTYS Drug Patent Profile
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When do Ongentys patents expire, 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. 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
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Summary for ONGENTYS
| International Patents: | 123 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ONGENTYS
*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 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 | |||
| Amneal | ONGENTYS | opicapone | CAPSULE;ORAL | 212489-002 | Apr 24, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Amneal | ONGENTYS | opicapone | CAPSULE;ORAL | 212489-001 | Apr 24, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| Spain | 2545178 | ⤷ Sign Up | |
| Poland | 1907382 | ⤷ Sign Up | |
| South Korea | 102023255 | ⤷ Sign Up | |
| South Korea | 20180096826 | 니트로카테콜 유도체를 포함하는 제약 제제 및 그의 제조 방법 (PHARMACEUTICAL FORMULATIONS COMPRISING NITROCATECHOL DERIVATIVES AND METHODS OF MAKING THEREOF) | ⤷ Sign Up |
| South Korea | 101370280 | ⤷ Sign Up | |
| Japan | 6239561 | ⤷ 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 | 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 | C 2016 044 | Romania | ⤷ Sign Up | PRODUCT NAME: OPICAPONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1066; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1066; DATE OF FIRST AUTHORISATION IN EEA: 20160624 |
| 1907382 | 122016000095 | Germany | ⤷ Sign Up | PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 20160624 |
| 1907382 | 132016000123029 | Italy | ⤷ Sign Up | PRODUCT NAME: OPICAPONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ONGENTYS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1066, 20160628 |
| 1907382 | PA2016036 | Lithuania | ⤷ Sign Up | PRODUCT NAME: OPIKAPONAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624 |
| 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.
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