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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 |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-14
Pay. Date : 2023-09-26
DMF Number : 37797
Submission : 2022-12-23
Status : Active
Type : II
NDC Package Code : 81912-0002
Start Marketing Date : 2023-09-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-15
DMF Number : 38810
Submission : 2023-09-28
Status : Active
Type : II
NDC Package Code : 59651-884
Start Marketing Date : 2024-01-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-21
Pay. Date : 2023-09-27
DMF Number : 38834
Submission : 2023-09-29
Status : Active
Type : II
NDC Package Code : 69766-112
Start Marketing Date : 2023-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-25
Pay. Date : 2023-08-24
DMF Number : 38655
Submission : 2023-08-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-08-14
DMF Number : 38715
Submission : 2023-09-28
Status : Active
Type : II
API Imports and Exports
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Average Price (USD/KGS) |
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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: ApprovedProduct Type: Small molecule
Sponsor: Biohaven Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Biohaven Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Vydura
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 10, 2023
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: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition October 03, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
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.
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : $11,600.0 million
October 03, 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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 09, 2022
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: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition May 10, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
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.
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : $11,600.0 million
May 10, 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: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 07, 2022
Details:
The results of the study showed that the excretion of Nurtec (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, into human milk is very low and rimegepant was safe and well tolerated by lactating women.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nurtec (rimegepant) Lactation Clinical Study Published in Breastfeeding Medicine Journal
Details : The results of the study showed that the excretion of Nurtec (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, into human milk is very low and rimegepant was safe and well tolerated by lactating women.
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 01, 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: Vydura
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Vydura
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Nurtec ODT
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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: BHV-3000
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : BHV-3000
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 14, 2022
(6S,9R)-6-(2,3-Difluorophenyl)-6,7,8,9-tetrahydro-...
CAS Number : 1190363-46-2
End Use API : Rimegepant Sulfate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
1-piperidin-4-yl-3H-imidazo[4,5-b]pyridin-2-one,di...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
2-oxo-1-(4-piperidinyl)-2,3- dihydro-1H-imidazo[4,...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
9-((triisopropylsilyl)oxy)-6,7,8,9- tetrahydro-5Hc...
CAS Number : 1190363-45-1
End Use API : Rimegepant Sulfate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
1-(Piperidin-4-yl)-1H-imidazo[4,5-b]pyridin-2(3H)-...
CAS Number : CAS-781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in ...
(6S,9R)-6-(2,3-Difluorophenyl)-6,7,8,9-tetrahydro-...
CAS Number : CAS-1190363-46-2
End Use API : Rimegepant Sulfate
About The Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in ...
7,8-Dihydro-5H- Cyclohepta[b]Pyridine-5,9(6H)-Dion...
CAS Number : 39713-40-1
End Use API : Rimegepant Sulfate
About The Company : Sanpra Synthesis strongly believes that with its expertise and innovative pharmaceutical business background, it is aptly positioned for APIs and intermediates ...
2,3-Pyridinedicarboxylic acid dimethyl ester
CAS Number : 605-38-9
End Use API : Rimegepant Sulfate
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
Dimethyl 5,9-dihydroxy-7H-cyclohepta[b]pyridine-6,...
CAS Number : 39713-36-5
End Use API : Rimegepant Sulfate
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
(9R)-9-tri(propan-2-yl)silyloxy-6,7,8,9-tetrahydro...
CAS Number : 1190363-45-1
End Use API : Rimegepant Sulfate
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
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