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    Chemistry

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    Also known as: Nurtec odt, Rimegepant sulfate [usan], 1374024-48-2, 1383nm3q0h, Rimegepant sulfate (usan), 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)
    Molecular Formula
    C56H64F4N12O13S
    Molecular Weight
    1221.2  g/mol
    InChI Key
    SOGUOEZRYKUOHR-CQZKMDJHSA-N
    FDA UNII
    1383NM3Q0H
    Rimegepant Sulfate
    1 2D Structure

    Rimegepant Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl] 4-(2-oxo-3H-imidazo[4,5-b]pyridin-1-yl)piperidine-1-carboxylate;sulfuric acid;trihydrate
    2.1.2 InChI
    InChI=1S/2C28H28F2N6O3.H2O4S.3H2O/c2*29-20-6-1-4-17(23(20)30)18-8-9-22(25-19(24(18)31)5-2-12-32-25)39-28(38)35-14-10-16(11-15-35)36-21-7-3-13-33-26(21)34-27(36)37;1-5(2,3)4;;;/h2*1-7,12-13,16,18,22,24H,8-11,14-15,31H2,(H,33,34,37);(H2,1,2,3,4);3*1H2/t2*18-,22+,24-;;;;/m00..../s1
    2.1.3 InChI Key
    SOGUOEZRYKUOHR-CQZKMDJHSA-N
    2.1.4 Canonical SMILES
    C1CC(C2=C(C=CC=N2)C(C1C3=C(C(=CC=C3)F)F)N)OC(=O)N4CCC(CC4)N5C6=C(NC5=O)N=CC=C6.C1CC(C2=C(C=CC=N2)C(C1C3=C(C(=CC=C3)F)F)N)OC(=O)N4CCC(CC4)N5C6=C(NC5=O)N=CC=C6.O.O.O.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C1C[C@H](C2=C(C=CC=N2)[C@H]([C@@H]1C3=C(C(=CC=C3)F)F)N)OC(=O)N4CCC(CC4)N5C6=C(NC5=O)N=CC=C6.C1C[C@H](C2=C(C=CC=N2)[C@H]([C@@H]1C3=C(C(=CC=C3)F)F)N)OC(=O)N4CCC(CC4)N5C6=C(NC5=O)N=CC=C6.O.O.O.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    1383NM3Q0H
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    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

    2.3.2 Depositor-Supplied Synonyms

    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

    2.4 Create Date
    2013-07-08
    3 Chemical and Physical Properties
    Molecular Weight 1221.2 g/mol
    Molecular Formula C56H64F4N12O13S
    Hydrogen Bond Donor Count9
    Hydrogen Bond Acceptor Count23
    Rotatable Bond Count8
    Exact Mass1220.43726396 g/mol
    Monoisotopic Mass1220.43726396 g/mol
    Topological Polar Surface Area313 Ų
    Heavy Atom Count86
    Formal Charge0
    Complexity973
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count6
    4 Pharmacology and Biochemistry
    4.1 FDA Pharmacological Classification
    4.1.1 Pharmacological Classes
    Calcitonin Gene-related Peptide Receptor Antagonists [MoA]; Calcitonin Gene-related Peptide Receptor Antagonist [EPC]

    API Reference Price

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Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725215400,"product":"RIMEGEPANT (QTY: 0.25 KGS)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"M\/S HANGZHOU ALLSINO CHEMICALS CO.,LTD","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"14000","totalValueFC":"3543.8","currency":"USD","unitRateINR":"1187900","date":"02-Sep-2024","totalValueINR":"296975","totalValueInUsd":"3543.8","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5378228","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"4th Floor, Bldg 1, 39 Ke Ji Avenue Yuhang, Hangzhou, Zhejiang 311121 China CN","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"RIMEGEPANT SULFATE(BHV-3000\/RGP)","address":"101, SAPTAGIRI RESIDENCY,1-10-98\/A, CHIKOTI GARDENS, BEGUMPET,","city":"HYDERABAD, AP.","supplier":"CATALENT MICRON TECHNOLOGIES LTD.","supplierCountry":"UNITED KINGDOM","foreign_port":"HEATHROW APT\/LONDON","customer":"ESCIENTIA","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"250","unit":"GMS","unitRateFc":"12.4","totalValueFC":"3138.8","currency":"USD","unitRateINR":"1052.1","date":"05-Sep-2024","totalValueINR":"263035","totalValueInUsd":"3138.8","indian_port":"Vizag-APIICL SEZ","hs_no":"29333100","bill_no":"5437370","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"HEATHROW APT\/LONDON","supplierAddress":"Crossway Boulevard, Crossways Dartford, Kent. DA2 6QY SDNF United Kingdom","customerAddress":"101, SAPTAGIRI RESIDENCY,1-10-98\/A, CHIKOTI GARDENS, BEGUMPET,"}]
    05-Aug-2023
    30-Mar-2025
    KGS
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    Drugs in Development

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    • Development Update
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    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.


    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

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    01

    Pfizer Inc

    U.S.A
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    Pfizer Inc

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Rimegepant Sulfate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Biohaven Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    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

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    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.


    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

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    02

    Biohaven Pharmaceuticals

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed
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    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

    DEALS_DEV arrow-down

    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

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    Biohaven Underscores Depth of Migraine Portfolio with Data from Nurtec® ODT (rimegepant) Long-Term Open Label Study and Phase 3 Zavegepant Trial at 64t...

    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

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    03

    Biohaven Pharmaceuticals

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Rimegepant Sulfate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    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

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    Biohaven Presentation at AAN Showed Decreased Opioid Use in Migraine Patients Following Nurtec® ODT Therapy: A Real-World Administrative Claims Analysi...

    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

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    04

    Biohaven Pharmaceuticals

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Biohaven Pharmaceuticals

    U.S.A
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    AACR Annual meeting
    Not Confirmed
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    Lead Product(s) : Rimegepant Sulfate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    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

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    Biohaven and Pfizer Complete Collaboration Transaction for Commercialization of Rimegepant and Zavegepant Outside United States

    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

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    05

    Biohaven Pharmaceuticals

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Biohaven Pharmaceuticals

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    Not Confirmed
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    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

    DEALS_DEV arrow-down

    Biohaven and Pfizer Complete Collaboration Transaction for Commercialization of Rimegepant and Zav...

    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

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    Pfizer and Biohaven’s Vydura® (Rimegepant) Granted First Ever Marketing Authorization by European Commission for Both Acute Treatment of Migraine and...

    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

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    06

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Rimegepant Sulfate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Pfizer Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    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

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    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.


    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

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    07

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed
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    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

    DEALS_DEV arrow-down

    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

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    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 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

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    08

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed

    Biohaven Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Rimegepant Sulfate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Pfizer Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    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

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    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 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

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    Biohaven Pharmaceuticals

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    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

    DEALS_DEV arrow-down

    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

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    Biohaven and Pfizer Announce Positive Top-Line Results of Pivotal Trial of Rimegepant for the Acute Treatment of Migraine in China and South Korea

    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

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    Biohaven Pharmaceuticals

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    Lead Product(s) : Rimegepant Sulfate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Pfizer Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biohaven and Pfizer Announce Positive Top-Line Results of Pivotal Trial of Rimegepant for the Acut...

    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

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    Pfizer Inc

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    Regulatory Info : RX

    Registration Country : USA

    RIMEGEPANT SULFATE

    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

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    Regulatory Info :

    Registration Country : Switzerland

    Rimegepantum

    Brand Name : Vydura ODT

    Dosage Form : Schmelztabl

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Switzerland

    Rimegepantum

    Brand Name : Vydura ODT

    Dosage Form : Schmelztabl

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Switzerland

    Rimegepantum

    Brand Name : Vydura ODT

    Dosage Form : Schmelztabl

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Egypt.png
    Rimegepant Sulfate API needed in Egypt [ENA22108]
    A company that focuses on research, development and manufacturing of OSDs, semi-solids and liquids is looking for suppliers of Rimegepant Sulfate API for development purposes. The suppliers must support this enquiry with ODMF & CoA.
    17 Feb 2025

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    17 Feb 2025

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    17 Feb 2025

    india-flag.png
    Rimegepant Sulfate (1 kg) API needed in India [ENA21874]
    A formulation development company that focuses on injectables, ophthalmics, semi-solids, and liquid oral-based products is looking for suppliers of Rimegepant Sulfate (1 kg) API for both development & commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    25 Jan 2025

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    25 Jan 2025

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    25 Jan 2025

    india-flag.png
    Rimegepant API needed in India [ENA20391]
    A company that focuses strongly on development and manufacturing of products in various specialties including antibiotics, anti-allergic, anti-inflammatory, anti-hypertensive, antacids, anti-infective, anti-malarial & respiratory is looking for suppliers of Rimegepant API for development purposes. The suppliers must support this enquiry with ODMF & CoA.
    29 Aug 2024

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    29 Aug 2024

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    29 Aug 2024

    india-flag.png
    Rimegepant Sulfate API needed in India [ENA20206]
    A CMO that focuses on manufacturing of various finished dosage formulations including tablets, capsules, liquid orals, ointment, hormonal gels, bi-layered and sustained release preparations is looking for suppliers of Rimegepant Sulfate API for development purposes. The suppliers must support this enquiry with CoA.
    07 Aug 2024

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    07 Aug 2024

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    07 Aug 2024

    Brazil.png
    Rimegepant API needed in Brazil [ENA14251]
    A large pharmaceutical manufacturing company that focused in portfolios like dermatological, cardiological, gynecological, gastric, oncology, respiratory & CNS is looking for suppliers of Rimegepant API for development purpose. The suppliers must support this enquiry with CoA.
    07 Jul 2022

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    07 Jul 2022

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    07 Jul 2022

    Egypt.png
    Rimegepant Sulfate API needed in Egypt [ENA13523]
    A company that deals in various pharmaceutical products is looking for suppliers of Rimegepant Sulfate API for commercial purpose. The required quantity is 1 kg - 5 kg. The suppliers must support this enquiry with CoA.
    04 May 2022

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    04 May 2022

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    04 May 2022

    Bangladesh.png
    Various APIs needed in Bangladesh [ENA09472]
    Skyrun Corporation, a trading house based in Bangladesh is looking for suppliers of Various APIs for development and commercial purposes. The required quantity is MOQ for each. Interested suppliers can contact them via their email: skyrun.kamrul@gmail.com. 1. USP Grade Acetylcystein 2. INN Grade Cefiderocol Sulfate Tosylate 3. USP Grade Diethylpropion HCL 4. INN Grade Lemborexant 5. INN Grade Mucopolysaccharide Polysulphate 6. BP Grade Nabumetone 7. Palonosetron HCL 8. BP Grade Phenoxymethyl Penicillin 9. INN Grade Remimazolam 10. INN Grade Rimegepant 11. INN Grade Sarecycline
    11 Jan 2021

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    11 Jan 2021

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    11 Jan 2021

    Bangladesh.png
    Various APIs needed in Bangladesh [ENA09273]
    Prime International, a pharmaceutical company specialising in veterinary products is looking for suppliers of Various APIs for one of its clients. The required quantity is MOQ for each. The suppliers must support this enquiry with DMF, USDMF, CEP and GMP. Interested suppliers can contact them via their email: robiul@grandgroupbd.com. 1. Opicapone API 2. Cefiderocol API 3. Diethylpropion API 4. Rimegepant API 5. Sarecycline API
    12 Dec 2020

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    12 Dec 2020

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    12 Dec 2020

    SaudiArabia.png
    Rimegepant (2 kg) API needed in Saudi Arabia [ENA08788]
    A pharmaceutical company that deals in both manufacturing and R&D is looking for suppliers of Rimegepant (2 kg) API for research purposes. The suppliers must support this enquiry with DMF (closed part to be submitted to the Saudi FDA directly).
    12 Oct 2020

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    12 Oct 2020

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    12 Oct 2020

    Bangladesh.png
    Various APIs needed in Bangladesh [ENA08553]
    BNS Pharma Solution, an indenting agent based in Bangladesh is looking for suppliers of Various APIs. The required quantity is MOQ for all. The suppliers must support this enquiry with CoA & GMP. Interested suppliers can contact them via their email: bnspharmasolution@gmail.com. 1. Itopride HCl API 2. Ibuprofen API 3. Bromelain API 4. Trypsin API 5. Rimegepant API 6. Biotin API
    15 Sep 2020

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    15 Sep 2020

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    15 Sep 2020

    Only 10 entries up to this point, click to access all click full view read-more
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    Patents & EXCLUSIVITIES

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    ABOUT THIS PAGE

    Looking for 1374024-48-2 / Rimegepant API manufacturers, exporters & distributors?

    Rimegepant manufacturers, exporters & distributors 1

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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.

    API | Excipient name

    Rimegepant

    Synonyms

    Nurtec odt, Rimegepant sulfate [usan], 1374024-48-2, 1383nm3q0h, Rimegepant sulfate (usan), 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)

    Cas Number

    1374024-48-2

    Unique Ingredient Identifier (UNII)

    1383NM3Q0H

    Nurtec odt (TN) Manufacturers

    A Nurtec odt (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nurtec odt (TN), including repackagers and relabelers. The FDA regulates Nurtec odt (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nurtec odt (TN) 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 Nurtec odt (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Nurtec odt (TN) Suppliers

    A Nurtec odt (TN) supplier is an individual or a company that provides Nurtec odt (TN) active pharmaceutical ingredient (API) or Nurtec odt (TN) finished formulations upon request. The Nurtec odt (TN) suppliers may include Nurtec odt (TN) API manufacturers, exporters, distributors and traders.

    click here to find a list of Nurtec odt (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Nurtec odt (TN) USDMF

    A Nurtec odt (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Nurtec odt (TN) active pharmaceutical ingredient (API) in detail. Different forms of Nurtec odt (TN) DMFs exist exist since differing nations have different regulations, such as Nurtec odt (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Nurtec odt (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Nurtec odt (TN) USDMF includes data on Nurtec odt (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nurtec odt (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Nurtec odt (TN) suppliers with USDMF on PharmaCompass.

    Nurtec odt (TN) KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Nurtec odt (TN) Drug Master File in Korea (Nurtec odt (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nurtec odt (TN). The MFDS reviews the Nurtec odt (TN) KDMF as part of the drug registration process and uses the information provided in the Nurtec odt (TN) KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Nurtec odt (TN) 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 Nurtec odt (TN) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Nurtec odt (TN) suppliers with KDMF on PharmaCompass.

    Nurtec odt (TN) NDC

    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 Nurtec odt (TN) as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Nurtec odt (TN) API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 Nurtec odt (TN) 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Nurtec odt (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nurtec odt (TN) NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Nurtec odt (TN) suppliers with NDC on PharmaCompass.

    Nurtec odt (TN) GMP

    Nurtec odt (TN) 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 Nurtec odt (TN) 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 Nurtec odt (TN) GMP manufacturer or Nurtec odt (TN) GMP API supplier for your needs.

    Nurtec odt (TN) CoA

    A Nurtec odt (TN) CoA (Certificate of Analysis) is a formal document that attests to Nurtec odt (TN)'s compliance with Nurtec odt (TN) specifications and serves as a tool for batch-level quality control.

    Nurtec odt (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Nurtec odt (TN) 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.

    Nurtec odt (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Nurtec odt (TN) EP), Nurtec odt (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nurtec odt (TN) USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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