ONGENTYS Drug Patent Profile
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Which patents cover Ongentys, and what generic alternatives are available?
Ongentys is a drug marketed by Neurocrine and is included in one NDA. There are nine patents protecting this drug.
This drug has one hundred and twenty-eight 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 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
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 |
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 |
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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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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