OPICAPONE - Generic Drug Details
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What are the generic drug sources for opicapone and what is the scope of freedom to operate?
Opicapone
is the generic ingredient in one branded drug marketed by Neurocrine and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Opicapone has one hundred and thirty-two patent family members in thirty-one countries.
There is one drug master file entry for opicapone. Two suppliers are listed for this compound.
Summary for OPICAPONE
| International Patents: | 132 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 20 |
| Patent Applications: | 160 |
| What excipients (inactive ingredients) are in OPICAPONE? | OPICAPONE excipients list |
| DailyMed Link: | OPICAPONE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OPICAPONE
Generic Entry Date for OPICAPONE*:
Constraining patent/regulatory exclusivity:
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 OPICAPONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| SK Chemicals Co., Ltd. | Phase 4 |
| Neurocrine Biosciences | Phase 1 |
| Bial - Portela C S.A. | Phase 4 |
Pharmacology for OPICAPONE
| Drug Class | Catechol-O-Methyltransferase Inhibitor |
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
US Patents and Regulatory Information for OPICAPONE
| 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 | 212489-002 | Apr 24, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | Y | Y | ⤷ Try a Trial | ||
| Neurocrine | ONGENTYS | opicapone | CAPSULE;ORAL | 212489-002 | Apr 24, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 OPICAPONE
| 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 OPICAPONE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 6721558 | ⤷ Try a Trial | |
| Australia | 2007346018 | Dosage regimen for COMT inhibitors | ⤷ Try a Trial |
| Japan | 2009544571 | ⤷ Try a Trial | |
| Russian Federation | 2009132188 | РЕЖИМ ДОЗИРОВАНИЯ ИНГИБИТОРОВ КОМТ | ⤷ Try a Trial |
| Russian Federation | 2008101265 | ПРОИЗВОДНЫЕ НИТРОКАТЕХОЛА В КАЧЕСТВЕ ИНГИБИТОРОВ СОМТ | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPICAPONE
| 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 | 16C1016 | France | ⤷ Try a Trial | PRODUCT NAME: OPICAPONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/1066 20160628 |
| 1907382 | 57/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 (MITTEILUNG) 20160628 |
| 1907382 | 122016000095 | Germany | ⤷ Try a Trial | PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 20160624 |
| 1907382 | 706 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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