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1. (5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta(b)pyridin-9-yl 4-(2-oxo-2,3-dihydro-1h-imidazo(4,5-b)pyridin-1-yl)piperidine-1-carboxylate
2. Bms-927711
3. Nurtec Odt
4. Rimegepant
1. Nurtec Odt
2. Rimegepant Sulfate [usan]
3. 1374024-48-2
4. 1383nm3q0h
5. Rimegepant Sulfate (usan)
6. 1-piperidinecarboxylic Acid, 4-(2,3-dihydro-2-oxo-1h-imidazo(4,5-b)pyridin-1-yl)-, (5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta(b)pyridin-9-yl Ester, Sulfate, Hydrate (2:1:3)
7. Di((5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta(b)pyridin-9-yl 4-(2-oxo-2,3-dihydro-1h-imidazo(4,5-b)pyridin-1-yl)piperidine-1-carboxylate), Monosulfate, Trihydrate
8. Unii-1383nm3q0h
9. Nurtec Odt (tn)
10. Rimegepant Sulfate Dihydrate
11. Chembl2364629
12. Dtxsid60160174
13. Rimegepant Sulfate [who-dd]
14. Rimegepant Sulfate [orange Book]
15. Rimegepant Hemisulfate Sesquihydrate
16. D10663
17. Rimegepant Hemisulfate Sesquihydrate [mi]
18. Q27251488
Molecular Weight | 1221.2 g/mol |
---|---|
Molecular Formula | C56H64F4N12O13S |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 23 |
Rotatable Bond Count | 8 |
Exact Mass | 1220.43726396 g/mol |
Monoisotopic Mass | 1220.43726396 g/mol |
Topological Polar Surface Area | 313 Ų |
Heavy Atom Count | 86 |
Formal Charge | 0 |
Complexity | 973 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 6 |
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Details:
Vydura (also known as Rimegepant) is an oral lyophilisate and is the first calcitonin gene-related peptide (CGRP) receptor antagonist migraine therapy to be accepted by the SMC.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Vydura
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Biohaven Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2023
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Biohaven Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
First-In-Class Migraine Treatment Vydura Approved for NHS Scotland
Details : Vydura (also known as Rimegepant) is an oral lyophilisate and is the first calcitonin gene-related peptide (CGRP) receptor antagonist migraine therapy to be accepted by the SMC.
Product Name : Vydura
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 05, 2023
Details:
Pfizer will acquire Biohaven, the maker of NURTEC® ODT (rimegepant sulfate). Pfizer will commercialize NURTEC® ODT, an innovative compound for the prevention and acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition October 05, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $11,600.0 million
Deal Type : Acquisition
Pfizer to Acquire Biohaven Pharmaceuticals
Details : Pfizer will acquire Biohaven, the maker of NURTEC® ODT (rimegepant sulfate). Pfizer will commercialize NURTEC® ODT, an innovative compound for the prevention and acute treatment of migraine.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : $11,600.0 million
October 05, 2022
Details:
Results from long-term studies of Nurtec ODT (Rimegepant Sulfate) as a preventive and acute treatment of migraine showed more than 80% of patients achieved ≥50% reduction in moderate or severe monthly migraine days and approximately half experienced a 100% reduction.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 06, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven Underscores Depth of Migraine Portfolio with Data from Nurtec® ODT (rimegepant) Long-Ter...
Details : Results from long-term studies of Nurtec ODT (Rimegepant Sulfate) as a preventive and acute treatment of migraine showed more than 80% of patients achieved ≥50% reduction in moderate or severe monthly migraine days and approximately half experienced a ...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 06, 2022
Details:
Results demonstrate a clinically meaningful reduction in opioid use of Nurtec® ODT (rimegepant) for patient population and may be of benefit to those reliant on opioids to manage their disease, thereby alleviating potential negative consequences of opioid use.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven Presentation at AAN Showed Decreased Opioid Use in Migraine Patients Following Nurtec® O...
Details : Results demonstrate a clinically meaningful reduction in opioid use of Nurtec® ODT (rimegepant) for patient population and may be of benefit to those reliant on opioids to manage their disease, thereby alleviating potential negative consequences of opio...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 04, 2022
Details:
The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of regulatory approvals and the satisfaction of other customary conditions and BHVN shares have been issued to Pfizer.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $1,240.0 million Upfront Cash: $500.0 million
Deal Type: Collaboration May 01, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $1,240.0 million
Deal Type : Collaboration
Details : The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of regulatory approvals and the satisfaction of other customary conditions and BHVN shares ha...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : $500.0 million
May 01, 2022
Details:
Results from the Phase 3 study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to placebo.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 27, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Pfizer and Biohaven’s Vydura® (Rimegepant) Granted First Ever Marketing Authorization by Europe...
Details : Results from the Phase 3 study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to placebo.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2022
Details:
The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including NURTEC® ODT (rimegepant), to address needs of millions of migraine patients worldwide.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition March 10, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $11,600.0 million
Deal Type : Acquisition
Pfizer Completes Acquisition of Biohaven Pharmaceuticals
Details : The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including NURTEC® ODT (rimegepant), to address needs of millions of migraine patients worldwide.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : $11,600.0 million
March 10, 2022
Details:
The CHMP of the EMA adopted a positive opinion for rimegepant, a CGRP receptor antagonist and, will now be reviewed by the European Commission, whose EU trade name will be VYDURA and it will be valid in all 27 EU member states for the treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven and Pfizer Receive Positive CHMP Opinion for Migraine Treatment
Details : The CHMP of the EMA adopted a positive opinion for rimegepant, a CGRP receptor antagonist and, will now be reviewed by the European Commission, whose EU trade name will be VYDURA and it will be valid in all 27 EU member states for the treatment of migrai...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 25, 2022
Details:
Nurtec ODT, oral calcitonin-gene related peptide receptor antagonist currently approved for the acute and preventive treatment of migraine. Prior research has implicated CGRP in pathophysiology of disease and suggested therapeutic benefits of CGRP antagonism.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Nurtec ODT
Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven Enrolls First Patient in Phase 2/3 Sinusitis Trial of Nurtec® ODT
Details : Nurtec ODT, oral calcitonin-gene related peptide receptor antagonist currently approved for the acute and preventive treatment of migraine. Prior research has implicated CGRP in pathophysiology of disease and suggested therapeutic benefits of CGRP antago...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 22, 2022
Details:
NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 14, 2022
Regulatory Info : RX
Registration Country : USA
Brand Name : NURTEC ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2020-02-27
Application Number : 212728
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Rimegepant 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 Rimegepant manufacturer or Rimegepant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rimegepant manufacturer or Rimegepant supplier.
PharmaCompass also assists you with knowing the Rimegepant API Price utilized in the formulation of products. Rimegepant API Price is not always fixed or binding as the Rimegepant Price is obtained through a variety of data sources. The Rimegepant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rimegepant Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimegepant Sulfate, including repackagers and relabelers. The FDA regulates Rimegepant Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimegepant Sulfate 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 Rimegepant Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rimegepant Sulfate supplier is an individual or a company that provides Rimegepant Sulfate active pharmaceutical ingredient (API) or Rimegepant Sulfate finished formulations upon request. The Rimegepant Sulfate suppliers may include Rimegepant Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Rimegepant Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimegepant Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimegepant Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Rimegepant Sulfate DMFs exist exist since differing nations have different regulations, such as Rimegepant Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimegepant Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Rimegepant Sulfate USDMF includes data on Rimegepant Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimegepant Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimegepant Sulfate 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 Rimegepant Sulfate Drug Master File in Korea (Rimegepant Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rimegepant Sulfate. The MFDS reviews the Rimegepant Sulfate KDMF as part of the drug registration process and uses the information provided in the Rimegepant Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rimegepant Sulfate 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 Rimegepant Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rimegepant Sulfate suppliers with KDMF 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 Rimegepant Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rimegepant Sulfate 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 Rimegepant Sulfate 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 Rimegepant Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rimegepant Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rimegepant Sulfate suppliers with NDC on PharmaCompass.
Rimegepant Sulfate 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 Rimegepant Sulfate 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 Rimegepant Sulfate GMP manufacturer or Rimegepant Sulfate GMP API supplier for your needs.
A Rimegepant Sulfate CoA (Certificate of Analysis) is a formal document that attests to Rimegepant Sulfate's compliance with Rimegepant Sulfate specifications and serves as a tool for batch-level quality control.
Rimegepant Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Rimegepant Sulfate 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.
Rimegepant Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Rimegepant Sulfate EP), Rimegepant Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rimegepant Sulfate USP).