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Synopsis

Synopsis

REF. STANDARDS OR IMPURITIES

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USP

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JP

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FINISHED DOSAGE FORMULATIONS

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Canada

Canada

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South Africa

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Health Canada Patents

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Chemistry

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Also known as:
Molecular Formula
C15H10Cl2N4O6
Molecular Weight
413.2  g/mol
InChI Key
HVGGGVAREUUJQV-VIZOYTHASA-N

Opicapone
1 2D Structure

Opicapone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4E)-4-[3-(2,5-dichloro-4,6-dimethyl-1-oxidopyridin-1-ium-3-yl)-2H-1,2,4-oxadiazol-5-ylidene]-2-hydroxy-6-nitrocyclohexa-2,5-dien-1-one
2.1.2 InChI
InChI=1S/C15H10Cl2N4O6/c1-5-10(13(17)20(24)6(2)11(5)16)14-18-15(27-19-14)7-3-8(21(25)26)12(23)9(22)4-7/h3-4,22H,1-2H3,(H,18,19)/b15-7+
2.1.3 InChI Key
HVGGGVAREUUJQV-VIZOYTHASA-N
2.1.4 Canonical SMILES
CC1=C(C(=[N+](C(=C1Cl)C)[O-])Cl)C2=NC(=C3C=C(C(=O)C(=C3)O)[N+](=O)[O-])ON2
2.1.5 Isomeric SMILES
CC1=C(C(=[N+](C(=C1Cl)C)[O-])Cl)C2=N/C(=C\3/C=C(C(=O)C(=C3)O)[N+](=O)[O-])/ON2
2.2 Create Date
2007-02-12
3 Chemical and Physical Properties
Molecular Weight 413.2 g/mol
Molecular Formula C15H10Cl2N4O6
XLogP32.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count1
Exact Mass411.9977394 g/mol
Monoisotopic Mass411.9977394 g/mol
Topological Polar Surface Area142 Ų
Heavy Atom Count27
Formal Charge0
Complexity818
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

USDMF

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01

Bial-portela And Ca Sa

Portugal

USDMF

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Aus. Peptide Conference
Not Confirmed

01

Aus. Peptide Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32198

Submission : 2017-11-08

Status : Active

Type : II

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02

Bial Portela And Ca Sa

Portugal

USDMF

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Aus. Peptide Conference
Not Confirmed

02

Aus. Peptide Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34838

Submission : 2020-07-17

Status : Active

Type : II

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03

Hetero Labs Ltd

India

USDMF

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Aus. Peptide Conference
Not Confirmed

03

Aus. Peptide Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41566

Submission : 2025-03-27

Status : Active

Type : II

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Aus. Peptide Conference
Not Confirmed

04

Aus. Peptide Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38110

Submission : 2023-03-20

Status : Active

Type : II

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EU WC

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Opicapone IH

Date of Issue : 2022-12-09

Valid Till : 2025-12-03

Written Confirmation Number : WC-0457

Address of the Firm : Sy No 544, 545 & 546, Bhiknoor (V), Bhiknoor (M), Kamareddy-503101, Telangana, I...

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KDMF

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01

Patheon

U.S.A
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Patheon

U.S.A
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Aus. Peptide Conference
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Opicaphone

Registrant Name : SK Chemical Co., Ltd.

Registration Date : 2019-11-26

Registration Number : Su703-6-ND

Manufacturer Name : Patheon Austria GmbH & Co. K...

Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria@[Micronising Manufactory]Via Sottobisio 42a/c...

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"OPICAPONE","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"MSN LIFE SCIENCES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"LABORATORIOS LEGRAND S A","customerCountry":"COLOMBIA","quantity":"3.80","actualQuantity":"3.8","unit":"KGS","unitRateFc":"15000","totalValueFC":"56437.6","currency":"USD","unitRateINR":1261959.2,"date":"30-Dec-2024","totalValueINR":"4795444.96","totalValueInUsd":"56437.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"6874432","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753122600,"product":"OPICAPONE","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"MSN LIFE SCIENCES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"AROLA ADUANAS Y,","customerCountry":"SPAIN","quantity":"48.00","actualQuantity":"48","unit":"KGS","unitRateFc":"6000","totalValueFC":"284322.2","currency":"USD","unitRateINR":509801.12624999997,"date":"22-Jul-2025","totalValueINR":"24470454.06","totalValueInUsd":"284322.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3767904","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""}]
30-Dec-2024
22-Jul-2025
KGS
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Average Price (USD/KGS)

Number of Transactions

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Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

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Drugs in Development

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Details:

Under the agreement, Amneal will have exclusive rights to market and distribute ONGENTYS (opicapone), a highly-selective COMT inhibitor, which is approved by USFDA as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing Off episodes.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Amneal Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement December 07, 2023

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01

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Details : Under the agreement, Amneal will have exclusive rights to market and distribute ONGENTYS (opicapone), a highly-selective COMT inhibitor, which is approved by USFDA as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experi...

Product Name : Ongentys

Product Type : Miscellaneous

Upfront Cash : Undisclosed

December 07, 2023

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Details:

ONGENTYS (Opicapone) is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "OFF"episodes.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 24, 2022

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02

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : ONGENTYS (Opicapone) is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "OFF"episodes.

Product Name : Ongentys

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 24, 2022

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Details:

ONGENTYS (opicapone) is a reversible COMT inhibitor approved by the U.S. FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 15, 2022

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03

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : ONGENTYS (opicapone) is a reversible COMT inhibitor approved by the U.S. FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available ...

Product Name : Ongentys

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 15, 2022

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Details:

Results of the post-hoc analysis for ONGENTYS® (opicapone) Capsules indicate that 34.4% (332/964) of participants experienced an OFF episode before going to sleep for a mean duration of 1.8±1.2 hours.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 06, 2022

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04

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Results of the post-hoc analysis for ONGENTYS® (opicapone) Capsules indicate that 34.4% (332/964) of participants experienced an OFF episode before going to sleep for a mean duration of 1.8±1.2 hours.

Product Name : Ongentys

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 06, 2022

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Details:

Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 04, 2021

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05

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Details : Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 04, 2021

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Details:

Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 03, 2021

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06

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Details : Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 03, 2021

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Details:

Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 03, 2021

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07

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Details : Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 03, 2021

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Details:

Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Parkinson Disease.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 27, 2021

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08

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Bial

Portugal
arrow
Aus. Peptide Conference
Not Confirmed

Details : Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Parkinson Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 27, 2021

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Details:

Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 29, 2021

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09

SK Chemicals

South Korea
arrow
Aus. Peptide Conference
Not Confirmed

SK Chemicals

South Korea
arrow
Aus. Peptide Conference
Not Confirmed

Details : Opicapone is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Parkinson Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 29, 2021

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Details:

The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.


Lead Product(s): Opicapone,Inapplicable

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Bial

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 01, 2020

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Recipharm AB

Sweden
arrow
Aus. Peptide Conference
Not Confirmed

Recipharm AB

Sweden
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Aus. Peptide Conference
Not Confirmed

Details : The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.

Product Name : Ongentys

Product Type : Miscellaneous

Upfront Cash : Undisclosed

October 01, 2020

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INTERMEDIATE SUPPLIERS

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01

Aus. Peptide Conference
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CAS Number : 121-34-6

End Use API : Opicapone

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed
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CAS Number : 121-34-6

End Use API : Opicapone

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed
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CAS Number : 91591-63-8

End Use API : Opicapone

About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...

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Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed
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CAS Number : 6635-20-7

End Use API : Opicapone

About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...

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FDF Dossiers

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Aus. Peptide Conference
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OPICAPONE

Brand Name : ONGENTYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2020-04-24

Application Number : 212489

Regulatory Info : RX

Registration Country : USA

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Aus. Peptide Conference
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Aus. Peptide Conference
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OPICAPONE

Brand Name : ONGENTYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2020-04-24

Application Number : 212489

Regulatory Info : RX

Registration Country : USA

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Bial

Portugal
Aus. Peptide Conference
Not Confirmed
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Bial

Portugal
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Opicapone

Brand Name : Ongentys

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 24/06/2016

Application Number : 20141231000125

Regulatory Info : Approved

Registration Country : Sweden

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Bial

Portugal
Aus. Peptide Conference
Not Confirmed
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Bial

Portugal
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Aus. Peptide Conference
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Opicapone

Brand Name : Ongentys

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date : 24/06/2016

Application Number : 20141231000132

Regulatory Info : Approved

Registration Country : Sweden

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05

Bial

Portugal
Aus. Peptide Conference
Not Confirmed
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Bial

Portugal
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Opicapone

Brand Name : Ontilyv

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 21/02/2022

Application Number : 20210429000091

Regulatory Info : Approved

Registration Country : Sweden

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Bial

Portugal
Aus. Peptide Conference
Not Confirmed
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Bial

Portugal
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Aus. Peptide Conference
Not Confirmed

Opicapone

Brand Name : Ontilyv

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date : 21/02/2022

Application Number : 20210429000107

Regulatory Info : Approved

Registration Country : Sweden

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Country
Aus. Peptide Conference
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Country
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Opicapone

Brand Name : Ongentys

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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FDA Orange Book

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01

AMNEAL

U.S.A
Aus. Peptide Conference
Not Confirmed
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AMNEAL

U.S.A
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Aus. Peptide Conference
Not Confirmed

OPICAPONE

Brand Name : ONGENTYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 2020-04-24

Application Number : 212489

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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AMNEAL

U.S.A
Aus. Peptide Conference
Not Confirmed
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AMNEAL

U.S.A
arrow
Aus. Peptide Conference
Not Confirmed

OPICAPONE

Brand Name : ONGENTYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Approval Date : 2020-04-24

Application Number : 212489

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Digital Content read-more

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NEWS #PharmaBuzz

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Global Sales Information

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US Medicaid Prescriptions

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01

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Company : Neurocrine/Amne

Opicapone

Drug Cost (USD) : 15,941,380

Year : 2023

Prescribers : 3270

Prescriptions : 16716

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Not Confirmed
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Aus. Peptide Conference
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Company : Neurocrine Bios

Opicapone

Drug Cost (USD) : 11,855,741

Year : 2022

Prescribers : 2987

Prescriptions : 13687

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Aus. Peptide Conference
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Aus. Peptide Conference
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Company : Neurocrine Bios

Opicapone

Drug Cost (USD) : 6,710,087

Year : 2021

Prescribers : 2256

Prescriptions : 8597

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Not Confirmed
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Aus. Peptide Conference
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Company : Neurocrine Bios

Opicapone

Drug Cost (USD) : 545,253

Year : 2020

Prescribers : 464

Prescriptions : 693

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Annual Reports

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01

Brand Name : Ongentys

Opicapone

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Aus. Peptide Conference
Not Confirmed

Brand Name : Ongentys

U.S.A
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2020 Revenue in Millions : 1

2019 Revenue in Millions : 0

Growth (%) : 100

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Brand Name : Ongentys

Opicapone

arrow
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Not Confirmed

Brand Name : Ongentys

Japan
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2021 Revenue in Millions : 17

2020 Revenue in Millions : 0

Growth (%) : 100

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Brand Name : Ongentys

Opicapone

arrow
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Not Confirmed

Brand Name : Ongentys

U.S.A
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2021 Revenue in Millions : 8

2020 Revenue in Millions : 1

Growth (%) : 720

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Brand Name : Ongentys

Opicapone

arrow
Aus. Peptide Conference
Not Confirmed

Brand Name : Ongentys

Japan
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2022 Revenue in Millions : 36

2021 Revenue in Millions : 17

Growth (%) : 114

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Brand Name : Ongentys

Opicapone

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Aus. Peptide Conference
Not Confirmed

Brand Name : Ongentys

U.S.A
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2022 Revenue in Millions : 13

2021 Revenue in Millions : 8

Growth (%) : 60

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Brand Name : Ongentys

Opicapone

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Aus. Peptide Conference
Not Confirmed

Brand Name : Ongentys

Japan
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2023 Revenue in Millions : 41

2022 Revenue in Millions : 36

Growth (%) : 30

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Brand Name : Ongentys

Opicapone

arrow
Aus. Peptide Conference
Not Confirmed

Brand Name : Ongentys

Japan
arrow
Aus. Peptide Conference
Not Confirmed

Opicapone

Main Therapeutic Indication : Neurology

Currency : USD

2024 Revenue in Millions : 48

2023 Revenue in Millions : 41

Growth (%) : 17

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Looking for / Opicapone API manufacturers, exporters & distributors?

Opicapone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Opicapone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Opicapone manufacturer or Opicapone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Opicapone manufacturer or Opicapone supplier.

PharmaCompass also assists you with knowing the Opicapone API Price utilized in the formulation of products. Opicapone API Price is not always fixed or binding as the Opicapone Price is obtained through a variety of data sources. The Opicapone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Opicapone

Opicapone Manufacturers

A Opicapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Opicapone, including repackagers and relabelers. The FDA regulates Opicapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Opicapone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Opicapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Opicapone Suppliers

A Opicapone supplier is an individual or a company that provides Opicapone active pharmaceutical ingredient (API) or Opicapone finished formulations upon request. The Opicapone suppliers may include Opicapone API manufacturers, exporters, distributors and traders.

click here to find a list of Opicapone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Opicapone USDMF

A Opicapone DMF (Drug Master File) is a document detailing the whole manufacturing process of Opicapone active pharmaceutical ingredient (API) in detail. Different forms of Opicapone DMFs exist exist since differing nations have different regulations, such as Opicapone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Opicapone DMF submitted to regulatory agencies in the US is known as a USDMF. Opicapone USDMF includes data on Opicapone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Opicapone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Opicapone suppliers with USDMF on PharmaCompass.

Opicapone KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Opicapone Drug Master File in Korea (Opicapone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Opicapone. The MFDS reviews the Opicapone KDMF as part of the drug registration process and uses the information provided in the Opicapone KDMF to evaluate the safety and efficacy of the drug.

After submitting a Opicapone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Opicapone API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Opicapone suppliers with KDMF on PharmaCompass.

Opicapone WC

A Opicapone written confirmation (Opicapone WC) is an official document issued by a regulatory agency to a Opicapone manufacturer, verifying that the manufacturing facility of a Opicapone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Opicapone APIs or Opicapone finished pharmaceutical products to another nation, regulatory agencies frequently require a Opicapone WC (written confirmation) as part of the regulatory process.

click here to find a list of Opicapone suppliers with Written Confirmation (WC) on PharmaCompass.

Opicapone NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Opicapone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Opicapone API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Opicapone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Opicapone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Opicapone NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Opicapone suppliers with NDC on PharmaCompass.

Opicapone GMP

Opicapone Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Opicapone GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Opicapone GMP manufacturer or Opicapone GMP API supplier for your needs.

Opicapone CoA

A Opicapone CoA (Certificate of Analysis) is a formal document that attests to Opicapone's compliance with Opicapone specifications and serves as a tool for batch-level quality control.

Opicapone CoA mostly includes findings from lab analyses of a specific batch. For each Opicapone CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Opicapone may be tested according to a variety of international standards, such as European Pharmacopoeia (Opicapone EP), Opicapone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Opicapone USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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