Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
FDF
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Annual Reports
NA
1. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, Carbamate (ester), (alphar)-
2. Carbamic Acid (r)-(+)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl Ester
3. Xcopri
4. Ykp-3089
5. Ykp3089
1. Xcopri
2. 913088-80-9
3. Cenobamate [inn]
4. Ykp3089
5. Ykp-3089
6. P85x70rzws
7. [(1r)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] Carbamate
8. Carbamic Acid (r)-(+)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl Ester
9. Ontozry
10. Unii-p85x70rzws
11. Xcopri (tn)
12. Cenobamate [mi]
13. Ykp-3089 Cenobamate
14. Cenobamate (usan/inn)
15. Cenobamate [usan:inn]
16. Cenobamate [usan]
17. Cenobamate [who-dd]
18. Schembl1682643
19. Cenobamate [orange Book]
20. Chembl3989949
21. Gtpl10773
22. Ykp3089ykp3089
23. Dtxsid001027948
24. Ex-a3604
25. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, 2-carbamate, (alphar)-
26. Db06119
27. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, Carbamate (ester), (alphar)-
28. Hy-17607
29. Cs-0014686
30. D11150
31. Q27286352
32. (1r)-1-(2-chlorophenyl)-2-(tetrazol-yl)ethyl)carbamate
33. (1r)-1-(2-chlorophenyl)-2-(2h-1,2,3,4-tetrazol-2-yl)ethyl Carbamate
34. (1r)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl Carbamate
35. 2h-tetrazole-2-ethanol, .alpha.-(2-chlorophenyl)-, 2-carbamate, (.alpha.r)-
36. 2h-tetrazole-2-ethanol, .alpha.-(2-chlorophenyl)-, Carbamate (ester), (.alpha.r)-
37. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, Yl)ethyl)carbamate Carbamate (ester), (.alpha.r)-
Molecular Weight | 267.67 g/mol |
---|---|
Molecular Formula | C10H10ClN5O2 |
XLogP3 | 1.5 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 5 |
Exact Mass | 267.0523023 g/mol |
Monoisotopic Mass | 267.0523023 g/mol |
Topological Polar Surface Area | 95.9 Ų |
Heavy Atom Count | 18 |
Formal Charge | 0 |
Complexity | 293 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Cenobamate is indicated for the treatment of partial onset seizures in adults.
Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
The mechanism of cenobamate is unknown, however it modulates GABAA and inhibit voltage gated sodium channels. Cenobamate is given once daily and so it has a long duration of action. The therapeutic window is wide as doses of 750mg can be well tolerated. Patients should be counselled regarding the risk of DRESS syndrome, QT interval shortening, suicidal behavior, and neurological adverse effects.
Anticonvulsants
Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)
N03AX
N - Nervous system
N03 - Antiepileptics
N03A - Antiepileptics
N03AX - Other antiepileptics
N03AX25 - Cenobamate
Absorption
Cenobamate is 88% orally bioavailable with a Tmax of 1-4 hours. A high fat meal does not significantly impact the pharmacokinetics of cenobamate.
Route of Elimination
Cenobamate is 87.8% eliminated in the urine and 5.2% in the feces.
Volume of Distribution
The apparent volume of distribution of cenobamate is 40-50L.
Clearance
The apparent oral clearance of cenobamate is 0.45-0.63L/h for a 100-400mg/day dose.
Data regarding the metabolism of cenobamate is lacking, however it is mostly glucuronidated by UGT2B7 and UGT2B4 or oxidized by a number of cytochromes.
The terminal half life of cenobamate is 50-60h.
Cenobamate inhibits voltage gated sodium channels and is a positive GABAA modulator. However, the exact mechanism of action remains unknown. Inhibition of voltage gated sodium channels increases the threshold for generating action potentials and decreases the number of action potentials.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Global Sales Information
Company :
Cenobamate
Drug Cost (USD) : 68,154,842
Year : 2022
Prescribers : 6411
Prescriptions : 53354
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Cenobamate
Drug Cost (USD) : 32,547,978
Year : 2021
Prescribers : 4124
Prescriptions : 28039
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 100mg
Price Per Pack (Euro) : 50.63
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 100mg
Price Per Pack (Euro) : 101.26
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 150mg
Price Per Pack (Euro) : 50.63
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 150mg
Price Per Pack (Euro) : 101.26
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 200mg
Price Per Pack (Euro) : 50.63
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 200mg
Price Per Pack (Euro) : 101.26
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 50mg
Price Per Pack (Euro) : 50.63
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 50mg
Price Per Pack (Euro) : 101.26
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Arvelle Therapeutics International ...
Dosage Form : Filmtabl
Dosage Strength : 12.5mg and 25mg
Price Per Pack (Euro) : 101.26
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Tablet, film-coated
Dosage Strength : 200 mg
Price Per Pack (Euro) : 111.46
Published in :
Country : Norway
RX/OTC/DISCN :
Market Place
Patents & EXCLUSIVITIES
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-03-10
Application Number : 212839
Product Number : 3
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-03-10
Application Number : 212839
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-03-10
Application Number : 212839
Product Number : 4
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-03-10
Application Number : 212839
Product Number : 2
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-03-10
Application Number : 212839
Product Number : 5
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-03-10
Application Number : 212839
Product Number : 6
Exclusivity Details :
ABOUT THIS PAGE
50
PharmaCompass offers a list of Cenobamate 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 Cenobamate manufacturer or Cenobamate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cenobamate manufacturer or Cenobamate supplier.
PharmaCompass also assists you with knowing the Cenobamate API Price utilized in the formulation of products. Cenobamate API Price is not always fixed or binding as the Cenobamate Price is obtained through a variety of data sources. The Cenobamate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cenobamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cenobamate, including repackagers and relabelers. The FDA regulates Cenobamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cenobamate 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 Cenobamate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cenobamate supplier is an individual or a company that provides Cenobamate active pharmaceutical ingredient (API) or Cenobamate finished formulations upon request. The Cenobamate suppliers may include Cenobamate API manufacturers, exporters, distributors and traders.
click here to find a list of Cenobamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cenobamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cenobamate active pharmaceutical ingredient (API) in detail. Different forms of Cenobamate DMFs exist exist since differing nations have different regulations, such as Cenobamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cenobamate DMF submitted to regulatory agencies in the US is known as a USDMF. Cenobamate USDMF includes data on Cenobamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cenobamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cenobamate suppliers with USDMF on PharmaCompass.
A Cenobamate written confirmation (Cenobamate WC) is an official document issued by a regulatory agency to a Cenobamate manufacturer, verifying that the manufacturing facility of a Cenobamate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cenobamate APIs or Cenobamate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cenobamate WC (written confirmation) as part of the regulatory process.
click here to find a list of Cenobamate 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 Cenobamate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cenobamate 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 Cenobamate 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 Cenobamate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cenobamate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cenobamate suppliers with NDC on PharmaCompass.
Cenobamate 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 Cenobamate 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 Cenobamate GMP manufacturer or Cenobamate GMP API supplier for your needs.
A Cenobamate CoA (Certificate of Analysis) is a formal document that attests to Cenobamate's compliance with Cenobamate specifications and serves as a tool for batch-level quality control.
Cenobamate CoA mostly includes findings from lab analyses of a specific batch. For each Cenobamate 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.
Cenobamate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cenobamate EP), Cenobamate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cenobamate USP).