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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

API REF. PRICE (USD/KG)

$
$ 0

MARKET PLACE

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FDF

FINISHED DOSAGE FORMULATIONS

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Canada

Canada

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South Africa

South Africa

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Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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Health Canada Patents

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

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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CPHI Middle east
Not Confirmed

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CPHI Middle east
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32198

Submission : 2017-11-08

Status : Active

Type : II

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Bial Portela And Ca Sa

Portugal

USDMF

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CPHI Middle east
Not Confirmed

02

CPHI Middle east
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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CPHI Middle east
Not Confirmed
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INTERMEDIATES SUPPLIERS

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CPHI Middle east
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CPHI Middle east
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CAS Number : CAS-91591-63-8

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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CPHI Middle east
Not Confirmed
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CPHI Middle east
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CAS Number : CAS-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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03

CPHI Middle east
Not Confirmed
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CPHI Middle east
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CAS Number : CAS-881-68-5

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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CPHI Middle east
Not Confirmed
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CPHI Middle east
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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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CPHI Middle east
Not Confirmed
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CPHI Middle east
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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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FDA Orange Book

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01

AMNEAL

U.S.A
DDL Conference
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AMNEAL

U.S.A
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DDL 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
DDL Conference
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AMNEAL

U.S.A
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DDL 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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Australia

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01

MAXX PHARMA PTY LTD

Country
DDL Conference
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MAXX PHARMA PTY LTD

Country
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DDL Conference
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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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Digital Content read-more

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NEWS #PharmaBuzz

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Global Sales Information

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Market Place

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APIs

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

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DDL Conference
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AMNEAL

U.S.A
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DDL Conference
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OPICAPONE

US Patent Number : 10071085

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212489

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-31

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
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DDL Conference
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OPICAPONE

US Patent Number : 9550759

Drug Substance Claim :

Drug Product Claim :

Application Number : 212489

Patent Use Code : U-3872

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-07-26

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
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DDL Conference
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OPICAPONE

US Patent Number : 9745290

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212489

Patent Use Code : U-3869

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-10-10

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
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DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 10071085

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212489

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-31

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
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DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 8524746

Drug Substance Claim :

Drug Product Claim :

Application Number : 212489

Patent Use Code : U-3869

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-07-14

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
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DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 9630955

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212489

Patent Use Code : U-3869

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-12-12

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
arrow
DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 8907099

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212489

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-05-12

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
arrow
DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 8524746

Drug Substance Claim :

Drug Product Claim :

Application Number : 212489

Patent Use Code : U-3869

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-07-14

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
arrow
DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 9630955

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212489

Patent Use Code : U-3869

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-12-12

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DDL Conference
Not Confirmed

AMNEAL

U.S.A
arrow
DDL Conference
Not Confirmed

OPICAPONE

US Patent Number : 8168793

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212489

Patent Use Code : U-3869

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-04-02

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US Exclusivities

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01

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Antibody Engineering
Not Confirmed

AMNEAL

U.S.A
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Antibody Engineering
Not Confirmed

OPICAPONE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-04-24

Application Number : 212489

Product Number : 1

Exclusivity Details :

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Antibody Engineering
Not Confirmed

AMNEAL

U.S.A
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Antibody Engineering
Not Confirmed

OPICAPONE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-04-24

Application Number : 212489

Product Number : 2

Exclusivity Details :

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