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Synopsis

Synopsis

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Chemistry

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Also known as: Lasmiditan hemisuccinate, 439239-92-6, Lasmiditan succinate [usan], Ly683974, W64ybj346b, 439239-92-6 (succinate)
Molecular Formula
C42H42F6N6O8
Molecular Weight
872.8  g/mol
InChI Key
MSOIHUHNGPOCTH-UHFFFAOYSA-N
FDA UNII
W64YBJ346B

Lasmiditan
1 2D Structure

Lasmiditan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
butanedioic acid;2,4,6-trifluoro-N-[6-(1-methylpiperidine-4-carbonyl)pyridin-2-yl]benzamide
2.1.2 InChI
InChI=1S/2C19H18F3N3O2.C4H6O4/c2*1-25-7-5-11(6-8-25)18(26)15-3-2-4-16(23-15)24-19(27)17-13(21)9-12(20)10-14(17)22;5-3(6)1-2-4(7)8/h2*2-4,9-11H,5-8H2,1H3,(H,23,24,27);1-2H2,(H,5,6)(H,7,8)
2.1.3 InChI Key
MSOIHUHNGPOCTH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1CCC(CC1)C(=O)C2=NC(=CC=C2)NC(=O)C3=C(C=C(C=C3F)F)F.CN1CCC(CC1)C(=O)C2=NC(=CC=C2)NC(=O)C3=C(C=C(C=C3F)F)F.C(CC(=O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
W64YBJ346B
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2,4,6-trifluoro-n-(6-((1-methylpiperidin-4-yl)carbonyl)pyridin-2yl)benzamide

2. Col-144

3. Lasmiditan

4. Lasmiditan Hydrochloride

5. Ly573144

6. Reyvow

2.3.2 Depositor-Supplied Synonyms

1. Lasmiditan Hemisuccinate

2. 439239-92-6

3. Lasmiditan Succinate [usan]

4. Ly683974

5. W64ybj346b

6. 439239-92-6 (succinate)

7. Reyvow

8. Ly-573144

9. Ly-683974

10. 2,4,6-trifluoro-n-(6-((1-methylpiperidine-4-yl)carbonyl)pyridin-2-yl)benzamide Hemisuccinate

11. 2,4,6-trifluoro-n-(6-((1-methylpiperidine-4-yl)carbonyl)pyridin-2-yl)benzamide Succinic (2:1)

12. Unii-w64ybj346b

13. Reyvow (tn)

14. Chembl3039526

15. Dtxsid10195991

16. Lasmiditan Succinate (jan/usan)

17. Lasmiditan Succinate [jan]

18. Ex-a1654

19. Lasmiditan Hemisuccinate [mi]

20. S6489

21. Lasmiditan Succinate [who-dd]

22. Ac-30917

23. Bl166745

24. Lasmiditan Succinate [orange Book]

25. D10424

26. Q27292373

27. Butanedioic Acid;2,4,6-trifluoro-n-[6-(1-methylpiperidine-4-carbonyl)pyridin-2-yl]benzamide

2.4 Create Date
2010-11-01
3 Chemical and Physical Properties
Molecular Weight 872.8 g/mol
Molecular Formula C42H42F6N6O8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count18
Rotatable Bond Count11
Exact Mass872.29683129 g/mol
Monoisotopic Mass872.29683129 g/mol
Topological Polar Surface Area199 Ų
Heavy Atom Count62
Formal Charge0
Complexity623
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

RAYVOW is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Serotonin Receptor Agonists

Endogenous compounds and drugs that bind to and activate SEROTONIN RECEPTORS. Many serotonin receptor agonists are used as ANTIDEPRESSANTS; ANXIOLYTICS; and in the treatment of MIGRAINE DISORDERS. (See all compounds classified as Serotonin Receptor Agonists.)


5.2 ATC Code

N02CC08


API SUPPLIERS

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01

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Moehs Iberica

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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Mankind Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

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Shanghai Desano Chemical Pharmaceu...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Shanghai Desano Chemical Pharmaceu...

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Hubei Gedian Humanwell Pharmaceuti...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Hubei Gedian Humanwell Pharmaceuti...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Suzhou Biosyntech

China

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Suzhou Biosyntech

China

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SMS Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
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Apino Pharma

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
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Zhejiang Tianyu Pharmaceutical Co....

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
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Glenmark Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
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Glenmark Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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NDC API

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BioProcess International Europe
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LASMIDITAN

NDC Package Code : 63419-0580

Start Marketing Date : 2020-11-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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BioProcess International Europe
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LASMIDITAN

NDC Package Code : 63419-0576

Start Marketing Date : 2018-12-10

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689791400,"product":"LASMIDITAN HEMISUCCINATE IHS","address":"7-1-638 TO 643, 643\/1,FLAT NO. 302 ,,BHANU ENCLAVE, ERRAGADDA","city":"HYDERABAD,TELANGANA","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"TO THE OREDR OF .","customerCountry":"PAKISTAN","quantity":"1.80","actualQuantity":"1.8","unit":"KGS","unitRateFc":"2800","totalValueFC":"4952","currency":"USD","unitRateINR":226110.88499999998,"date":"20-Jul-2023","totalValueINR":"406999.593","totalValueInUsd":"4952","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"7-1-638 TO 643, 643\/1,FLAT NO. 302 ,,BHANU ENCLAVE, ERRAGADDA, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694111400,"product":"LASMIDITAN HEMISUCCINATE IHS SUCND LOT+WS.BATCH NO LAS-P\/23001,LAS-P\/23002","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"HIKMA PHARMACEUTICALS","customerCountry":"EGYPT","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"3700","totalValueFC":"36514.5","currency":"USD","unitRateINR":303100,"date":"08-Sep-2023","totalValueINR":"3031000","totalValueInUsd":"36514.5","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"3786892","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694370600,"product":"PHARMACEUTICALS RAW MATERIALS: LASMIDITAN HEMISUCCINATE BATCH NO LAS-P\/23001","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"STANDARD CHARTERED BANK","customerCountry":"BANGLADESH","quantity":"3.50","actualQuantity":"3.5","unit":"KGS","unitRateFc":"2500","totalValueFC":"8167.9","currency":"USD","unitRateINR":193714.28571428571,"date":"11-Sep-2023","totalValueINR":"678000","totalValueInUsd":"8167.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3839351","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705429800,"product":"LASMIDITAN HEMISUCCINATE IHS PHARMACEUTICAL RAW MATERIALS METROCHEM BATCH NO: LAS-P\/23001","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO SHAHJALAL ISLAMI BANK LTD,","customerCountry":"BANGLADESH","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"2500","totalValueFC":"7371.7","currency":"USD","unitRateINR":204225,"date":"17-Jan-2024","totalValueINR":"612675","totalValueInUsd":"7371.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6814501","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"PHARMACEUTICAL RAW MATERIAL LASMIDITAN HEMISUCCINATE IHS (MTDL 18), GST NO:37AADCM2691M1Z0, TAX INV NO:DD\/23-24\/1994","address":"277\/2,BHAVESHWAR VILLA,RD.NO.31,","city":"MUMBAI,MAHARASHTRA","supplier":"SANJAY CHEMICALS","supplierCountry":"INDIA","foreign_port":"NAIROBI","customer":"TO THE ORDER OF","customerCountry":"KENYA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"4645.5","totalValueFC":"6866.4","currency":"USD","unitRateINR":379821.02000000002,"date":"02-Feb-2024","totalValueINR":"569731.53","totalValueInUsd":"6866.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"7218879","productDescription":"API","marketType":"","country":"KENYA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"277\/2,BHAVESHWAR VILLA,RD.NO.31,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"LASMIDITAN HEMISUCCINATE IH (PHARMACEUTICAL RAW MATERIALS)","address":"M.K. SUNRISE APARTMENTS,","city":"N\/A","supplier":"JPR LABS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"QNB ALAHLI BANK","customerCountry":"EGYPT","quantity":"27.19","actualQuantity":"27.19","unit":"KGS","unitRateFc":"2000","totalValueFC":"51936.8","currency":"USD","unitRateINR":162302.86870172856,"date":"27-Dec-2024","totalValueINR":"4413015","totalValueInUsd":"51936.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6818005","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"M.K. SUNRISE APARTMENTS,, N\/A","customerAddress":""}]
20-Jul-2023
27-Dec-2024
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Drugs in Development

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Details:

Reyvow-Generic (lasmiditan hemisuccinate) belongs to the “selective serotonin receptor agonists” class of medications and is specifically designed to alleviate the symptoms associated with migraine.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow-Generic

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 01, 2024

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01

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : Reyvow-Generic (lasmiditan hemisuccinate) belongs to the “selective serotonin receptor agonists” class of medications and is specifically designed to alleviate the symptoms associated with migraine.

Product Name : Reyvow-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

May 01, 2024

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Details:

Reyvow (lasmiditan hemisuccinate) is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Eli Lilly

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 25, 2022

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02

Ildong Pharmaceutical

South Korea
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BioProcess International Europe
Not Confirmed

Ildong Pharmaceutical

South Korea
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BioProcess International Europe
Not Confirmed

Details : Reyvow (lasmiditan hemisuccinate) is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Inapplicable

August 25, 2022

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Details:

Rayvow will be available as 50 mg, 100 mg and 200 mg film-coated tablets. The active substance of Rayvow is lasmiditan, a 5-hydroxytriptamine 1F (5-HT1F) receptor agonist (ATC code: N02CC), effecting a decrease of neuropeptide release and an inhibition of pain pathways.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 23, 2022

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03

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Details : Rayvow will be available as 50 mg, 100 mg and 200 mg film-coated tablets. The active substance of Rayvow is lasmiditan, a 5-hydroxytriptamine 1F (5-HT1F) receptor agonist (ATC code: N02CC), effecting a decrease of neuropeptide release and an inhibition o...

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Inapplicable

June 23, 2022

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Details:

Reyvow (lasmiditan hemisuccinate) is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 21, 2022

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04

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Details : Reyvow (lasmiditan hemisuccinate) is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 21, 2022

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Details:

Under the agreement, Eli Lilly Japan will hold authorisation for marketing lasmiditan succinate, similar to the humanized anti-CGRP monoclonal antibody Emgality (galcanezumab), and Daiichi Sankyo will take charge of its distribution and sales after marketing approval.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Daiichi Sankyo

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 30, 2021

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05

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Eli Lilly

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Details : Under the agreement, Eli Lilly Japan will hold authorisation for marketing lasmiditan succinate, similar to the humanized anti-CGRP monoclonal antibody Emgality (galcanezumab), and Daiichi Sankyo will take charge of its distribution and sales after marke...

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Undisclosed

August 30, 2021

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Details:

Adults who took REYVOW C-V for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours compared to those taking placebo, according to results from the recently completed Phase 3 study CENTURION.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 09, 2020

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06

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Eli Lilly

U.S.A
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BioProcess International Europe
Not Confirmed

Details : Adults who took REYVOW C-V for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours compared to those taking placebo, according to results from the recently completed P...

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Inapplicable

November 09, 2020

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Details:

Reyvow (lasmiditan hemisuccinate) belongs to the “selective serotonin receptor agonists” class of medications and is specifically designed to alleviate the symptoms associated with migraine headaches.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 10, 2020

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07

Eli Lilly

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Eli Lilly

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Details : Reyvow (lasmiditan hemisuccinate) belongs to the “selective serotonin receptor agonists” class of medications and is specifically designed to alleviate the symptoms associated with migraine headaches.

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Inapplicable

June 10, 2020

blank

Details:

Reyvow (lasmiditan hemisuccinate) belongs to the “selective serotonin receptor agonists” class of medications and is specifically designed to alleviate the symptoms associated with migraine headaches.


Lead Product(s): Lasmiditan

Therapeutic Area: Neurology Brand Name: Reyvow

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 31, 2020

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08

Eli Lilly

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Eli Lilly

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Details : Reyvow (lasmiditan hemisuccinate) belongs to the “selective serotonin receptor agonists” class of medications and is specifically designed to alleviate the symptoms associated with migraine headaches.

Product Name : Reyvow

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 31, 2020

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Global Sales Information

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US Medicaid Prescriptions

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01

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BPI Europe
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Company :

Lasmiditan Succinate

Drug Cost (USD) : 8,278,681

Year : 2022

Prescribers : 2737

Prescriptions : 9933

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BPI Europe
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BPI Europe
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Company :

Lasmiditan Succinate

Drug Cost (USD) : 5,806,062

Year : 2021

Prescribers : 2331

Prescriptions : 7676

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Patents & EXCLUSIVITIES

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PharmaCompass offers a list of Lasmiditan Succinate 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 Lasmiditan Succinate manufacturer or Lasmiditan Succinate supplier for your needs.

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PharmaCompass also assists you with knowing the Lasmiditan Succinate API Price utilized in the formulation of products. Lasmiditan Succinate API Price is not always fixed or binding as the Lasmiditan Succinate Price is obtained through a variety of data sources. The Lasmiditan Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Lasmiditan Succinate

Synonyms

Lasmiditan hemisuccinate, 439239-92-6, Lasmiditan succinate [usan], Ly683974, W64ybj346b, 439239-92-6 (succinate)

Cas Number

439239-92-6

Unique Ingredient Identifier (UNII)

W64YBJ346B

Lasmiditan Manufacturers

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

Lasmiditan Suppliers

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

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

Lasmiditan USDMF

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

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

click here to find a list of Lasmiditan suppliers with USDMF on PharmaCompass.

Lasmiditan KDMF

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

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

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

click here to find a list of Lasmiditan suppliers with KDMF on PharmaCompass.

Lasmiditan 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 Lasmiditan as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Lasmiditan 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 Lasmiditan 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 Lasmiditan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lasmiditan NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Lasmiditan suppliers with NDC on PharmaCompass.

Lasmiditan GMP

Lasmiditan 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 Lasmiditan 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 Lasmiditan GMP manufacturer or Lasmiditan GMP API supplier for your needs.

Lasmiditan CoA

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

Lasmiditan CoA mostly includes findings from lab analyses of a specific batch. For each Lasmiditan 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.

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