Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Canada
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
Regulatory FDF Prices
NA
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Molecular Weight | 413.2 g/mol |
---|---|
Molecular Formula | C15H10Cl2N4O6 |
XLogP3 | 2.1 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 1 |
Exact Mass | 411.9977394 g/mol |
Monoisotopic Mass | 411.9977394 g/mol |
Topological Polar Surface Area | 142 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 818 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32198
Submission : 2017-11-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34838
Submission : 2020-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41566
Submission : 2025-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38110
Submission : 2023-03-20
Status : Active
Type : II
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...
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...
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
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
Lead Product(s) : Opicapone,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)
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
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
Lead Product(s) : Opicapone,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Opicapone,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Neurocrine Biosciences Presents New Post-Hoc Analysis of ONGENTYS® (opicapone) Capsules Effect on...
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
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
Lead Product(s) : Opicapone,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.
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
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
OpiCapone Effect on Motor Fluctuations and pAiN
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
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
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
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
Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)
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
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
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
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
Lead Product(s) : Opicapone,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bial
Deal Size : Undisclosed
Deal Type : Agreement
BIAL and Recipharm Expand Long-Term Supply Agreement for Opicapone API
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
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 ...
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 ...
2,5-Dichloro-4,6-dimethylnicotinonitrile
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...
4-Hydroxy-3-methoxy-5-nitrobenzaldehyde
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...
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ongentys
Dosage Form : Capsule
Dosage Strength : 25mg
Packaging :
Approval Date : 24/06/2016
Application Number : 20141231000125
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ongentys
Dosage Form : Capsule
Dosage Strength : 50mg
Packaging :
Approval Date : 24/06/2016
Application Number : 20141231000132
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontilyv
Dosage Form : Capsule
Dosage Strength : 25mg
Packaging :
Approval Date : 21/02/2022
Application Number : 20210429000091
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontilyv
Dosage Form : Capsule
Dosage Strength : 50mg
Packaging :
Approval Date : 21/02/2022
Application Number : 20210429000107
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : Australia
Brand Name : Ongentys
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
Global Sales Information
Company : Neurocrine/Amne
Opicapone
Drug Cost (USD) : 15,941,380
Year : 2023
Prescribers : 3270
Prescriptions : 16716
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Neurocrine Bios
Opicapone
Drug Cost (USD) : 11,855,741
Year : 2022
Prescribers : 2987
Prescriptions : 13687
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Neurocrine Bios
Opicapone
Drug Cost (USD) : 6,710,087
Year : 2021
Prescribers : 2256
Prescriptions : 8597
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Neurocrine Bios
Opicapone
Drug Cost (USD) : 545,253
Year : 2020
Prescribers : 464
Prescriptions : 693
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Main Therapeutic Indication : Neurology
Currency : USD
2020 Revenue in Millions : 1
2019 Revenue in Millions : 0
Growth (%) : 100
Main Therapeutic Indication : Neurology
Currency : USD
2021 Revenue in Millions : 17
2020 Revenue in Millions : 0
Growth (%) : 100
Main Therapeutic Indication : Neurology
Currency : USD
2021 Revenue in Millions : 8
2020 Revenue in Millions : 1
Growth (%) : 720
Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 36
2021 Revenue in Millions : 17
Growth (%) : 114
Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 13
2021 Revenue in Millions : 8
Growth (%) : 60
Main Therapeutic Indication : Neurology
Currency : USD
2023 Revenue in Millions : 41
2022 Revenue in Millions : 36
Growth (%) : 30
Main Therapeutic Indication : Neurology
Currency : USD
2024 Revenue in Millions : 48
2023 Revenue in Millions : 41
Growth (%) : 17
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
12
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Opicapone API and other APIs are published in this directory by the FDA.
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.
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 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.
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).