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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]

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HEATHROW","customer":"PROJECT MANAGER","customerCountry":"UNITED KINGDOM","quantity":"89.70","actualQuantity":"89.7","unit":"KGS","unitRateFc":"13010","totalValueFC":"1154703.2","currency":"USD","unitRateINR":1101947,"date":"28-Apr-2025","totalValueINR":"98844645.9","totalValueInUsd":"1154703.2","indian_port":"Bangalore Air","hs_no":"29333100","bill_no":"1349870","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT.NO.49,CANARA BANK ROAD,, PHASE-I,BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"FINE ORGANIC COMPOUND-WE INTEND TO CLAIMUNDER RODTEP SCHEME RIMEGEPANT SULFATE(BATCH NO:A012540094,A012540096,)","address":"PLOT.NO.49,CANARA BANK ROAD,","city":"PHASE-I,BANGALORE","supplier":"ANTHEM BIOSCIENCES LTD","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"PROJECT MANAGER","customerCountry":"UNITED KINGDOM","quantity":"180.00","actualQuantity":"180","unit":"KGS","unitRateFc":"13010","totalValueFC":"2317130.1","currency":"USD","unitRateINR":1101947,"date":"28-Apr-2025","totalValueINR":"198350460","totalValueInUsd":"2317130.1","indian_port":"Bangalore Air","hs_no":"29333100","bill_no":"1350073","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT.NO.49,CANARA BANK ROAD,, PHASE-I,BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"FINE ORGANIC COMPOUND-WE INTEND TO CLAIMUNDER RODTEP SCHEME RIMEGEPANT SULFATE(BATCH NO:A062440412, A062440427)","address":"PLOT.NO.49,CANARA BANK ROAD,","city":"PHASE-I,BANGALORE","supplier":"ANTHEM BIOSCIENCES LTD","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"PROJECT MANAGER","customerCountry":"UNITED KINGDOM","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"12660","totalValueFC":"4008522.2","currency":"USD","unitRateINR":1072302,"date":"28-Apr-2025","totalValueINR":"343136640","totalValueInUsd":"4008522.2","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"1349771","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT.NO.49,CANARA BANK ROAD,, PHASE-I,BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753468200,"product":"FINE ORGANIC COMPOUND WE INTEND TO CLAIMUNDER RODTEP SCHEME RIMEGEPANT SULFATE(B\/N:A0625400223)","address":"PLOT.NO.49,CANARA BANK ROAD,","city":"PHASE-I,BANGALORE","supplier":"ANTHEM BIOSCIENCES LTD","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"PROJECT MANAGER","customerCountry":"UNITED KINGDOM","quantity":"82.00","actualQuantity":"82","unit":"KGS","unitRateFc":"11498","totalValueFC":"932254.5","currency":"USD","unitRateINR":978479.79999999993,"date":"26-Jul-2025","totalValueINR":"80235343.6","totalValueInUsd":"932254.5","indian_port":"Bangalore Air","hs_no":"29333190","bill_no":"3898904","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT.NO.49,CANARA BANK ROAD,, PHASE-I,BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756924200,"product":"RIMEGEPANT SULFATE (RES)","address":"A-2,419, CELEBRATION CITY CENTER,,","city":"AHMEDABAD,GUJARAT","supplier":"APRAMEYA PHARMACHEM PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HONG KONG","customer":"SAN YANG FU LIMITED","customerCountry":"HONG KONG","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"15.3","totalValueFC":"7465.8","currency":"USD","unitRateINR":1317.998,"date":"04-Sep-2025","totalValueINR":"658999","totalValueInUsd":"7465.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"5013095","productDescription":"API","marketType":"","country":"HONG KONG","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-2,419, CELEBRATION CITY CENTER,,, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758738600,"product":"FINE ORGANIC COMPOUND - WE INTEND TO CLAIM UNDER RODTEP SCHEME RIMEGEPANT SULFATE (BATCH NO:A062540355,A062540364.A0625)","address":"PLOT.NO.49,CANARA BANK ROAD,","city":"PHASE-I,BANGALORE","supplier":"ANTHEM BIOSCIENCES LTD","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"PROJECT MANAGER","customerCountry":"UNITED KINGDOM","quantity":"251.70","actualQuantity":"251.7","unit":"KGS","unitRateFc":"11328","totalValueFC":"2815110.4","currency":"USD","unitRateINR":987235.1998410807,"date":"25-Sep-2025","totalValueINR":"248487099.8","totalValueInUsd":"2815110.4","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5649526","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"PLOT.NO.49,CANARA BANK ROAD,, PHASE-I,BANGALORE","customerAddress":""},{"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 ADVANCED SCIENCES PRIVATE LTD","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"RIMEGEPANT SULFATE RIMEGEPANT SULFATE","address":"L\/204, MANTRI WOODLANDS, B.G. ROAD,","city":"KARNATAKA STATE","supplier":"NANTONG CHANYOO PHARMATECH CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TENSHI KAIZEN PRIVATE LTD","customerCountry":"INDIA","quantity":"0.70","actualQuantity":"0.7","unit":"KGS","unitRateFc":"27850","totalValueFC":"19676.8","currency":"USD","unitRateINR":"2406240","date":"28-Apr-2025","totalValueINR":"1684368","totalValueInUsd":"19676.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"9760007","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO 2 TONGHAI SI ROAD YANGKOU CHEMIC AL INDUSTRIAL PARK RUDONG COASTAL E COOMIC JIANGSU, China","customerAddress":"L\/204, MANTRI WOODLANDS, B.G. ROAD,"}]
09-Feb-2022
25-Sep-2025
KGS
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FDA Orange Book

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01

PFIZER

U.S.A
CPhI India
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RIMEGEPANT SULFATE

Brand Name : NURTEC ODT

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2020-02-27

Application Number : 212728

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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Rimegepant Hemisulfate Sesquihydrate

Brand Name : Vydura

Dosage Form : Tablet

Dosage Strength : 75mg

Packaging :

Approval Date : 25/04/2022

Application Number : 20210212000017

Regulatory Info : Approved

Registration Country : Sweden

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Rimegepant Sulfate

Brand Name : Vydura

Dosage Form : Oral Lyophilized

Dosage Strength : 75MG

Packaging :

Approval Date : 2022-06-06

Application Number : 1221645002

Regulatory Info : Authorized

Registration Country : Spain

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DATA COMPILATION #PharmaFlow

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FDA approvals rise 49% in 2023; CRISPR’s gene editing therapy sees light of day
In 2022, when the US Food and Drug Administration (FDA) was reeling under the impact of the pandemic, new drug approvals by the agency dropped by 26 percent. But last year, FDA’s new drug approvals rebounded by an impressive 49 percent, with the Center for Drug Evaluation and Research (CDER) approving 55 new drugs in 2023. Of them, 36 percent were considered first-in-class, while small molecules made up for 62 percent of the total drugs approved (i.e. 34). FDA’s Center for Biologics Evaluation and Research (CBER) okayed 19 biologics in 2023 compared to eight in the previous year.The first half of 2023 saw the debut of vaccines for the all-too-common respiratory syncytial virus (RSV). Among the other notable approvals in H1 was Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab). Out of the total 55 drug approvals, 29 came in H2 2023. This includes Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy that relies on the Nobel Prize-winning CRISPR gene-editing technology. Casgevy has been approved as a treatment for sickle-cell disease (SCD) and β-thalassemia.While FDA witnessed a sharp rise in approvals in 2023, many other drug regulators didn’t. The European Medicines Agency (EMA) granted marketing authorization to 32 novel drugs in 2023, a fall from 33 in 2022. Similarly, Health Canada’s approvals in 2023 decreased to 38, compared to 45 in the previous year.As usual, oncology topped the list of drug approvals by therapeutic area, at 39 (as opposed to 35 in 2022). Rare diseases was the second most popular therapeutic area for drug approvals. With drugmakers clearly paying heed to the unmet needs of patients suffering from rare diseases, this therapeutic area sprinted from a 9 percent share and the fourth position among new approvals in 2022 to an impressive 34 percent share in 2023. A quarter of the new drug approvals were in infectious diseases, followed by immunology (19 percent) and neurology (7 percent).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Casgevy, postpartum depression drug Zurzuvae emerge as potential blockbustersGene therapy Casgevy, postpartum depression (PPD) med Zurzuvae, blood cancer med Elrexfio and ulcerative colitis drug Velsipity were some of the prominent approvals of 2023.Britain’s Medicines and Healthcare products Regulatory Agency was the first to okay Casgevy in November as a cure for SCD and β-thalassemia. Soon, the FDA approved it for SCD. In January this year, the American agency also approved it for transfusion-dependent β-thalassemia (TDT). Analysts estimate Casgevy to generate US$ 2.6 billion in peak sales, says Nature. Biogen and Sage’s PPD therapy Zurzuvae became the first and only FDA-approved pill for the condition that can be life-threatening for both the mother and the child. Global sales of Zurzuvae are forecast to hit US$ 1.28 billion by 2028.In August, Pfizer’s Elrexfio (elranatamab) became the first “off-the-shelf” (ready-to-use) therapy in the US for multiple myeloma. The drug provides an option for patients with hard to treat or relapsed blood cancer and is estimated to bring in US$ 861 million in peak sales by 2028, says Nature.Pfizer also bagged another significant approval in October — its drug Velsipity (etrasimod) was greenlit by the FDA to treat adults with ulcerative colitis, an inflammatory bowel disease. Peak revenue for Velsipity is expected to come in at US$ 825 million, as per Evaluate.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Astra’s Truqap, GSK’s Ojjaara among top cancer therapies given FDA nod in H2In November, FDA approved AstraZeneca’s Truqap (capivasertib) in combination with the Anglo-Swedish drugmaker’s Faslodex (fulvestrant) for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations. Evaluate Pharma forecasts peak Truqap sales to come in at about US$ 690 million.In September, FDA approved GSK’s Ojjaara (momelotinib) as the first and only treatment for myelofibrosis with anemia. Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease. Ojjaara is taken orally once a day.Other notable oncology treatments okayed by FDA in H2 2023 include Daiichi’s Vanflyta (quizartinib) in July to treat an aggressive blood cancer known as acute myeloid leukemia (AML). In August, FDA approved Janssen’s bispecific antibody Talvey (talquetamab-tgvs) for difficult-to-treat blood cancer. The agency approved two cancer therapies in November — BMS’ Augtyro (repotrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) and Takeda’s targeted oral therapy Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer (mCRC).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Rare disease drugs Santhera-Catalyst’s Agamree, Novo’s Rivfloza bag approval in H2In October, FDA approved Santhera Pharmaceuticals and Catalyst Pharma’s Agamree (vamorolone), an oral suspension treatment for Duchenne muscular dystrophy (DMD) in patients two years of age and older. This makes it the first drug fully approved in both the US and Europe for the muscle degeneration disorder. Agamree acts in a manner similar to other steroids, which are the standard of care for the inherited rare disease. However, it causes fewer side effects.FDA also okayed Novo Nordisk’s once-a-month injection Rivfloza (nedosiran) in October to treat a rare genetic condition — primary hyperoxaluria type 1 (PH1) — that causes recurring kidney stones.In November, the agency approved Takeda’s Adzynma (ADAMTS13, recombinant-krhn) as the first treatment for both adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare genetic blood disorder. Other noteworthy FDA approvals in H2 2023 for rare blood diseases include Novartis’ Fabhalta and bluebird bio's Lyfgenia. Fabhalta is the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria, a rare disease that causes symptoms such as hemolytic anemia, hemoglobinuria (excretion of hemoglobin in the urine), fatigue, shortness of breath etc. Lyfgenia is the first cell-based gene therapy for the treatment of SCD in patients 12 years and older. Similarly, another rare disease drug — Regeneron’s Veopoz —  bagged FDA approval in August last. Veopoz treats CHAPLE disease, an ultra-rare disease in which patients have severe gastrointestinal problems.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Our viewAfter a lull in 2022, new drug approvals have finally gathered momentum. The good news is that this year, several pathbreaking drugs are coming up for approval, such as Madrigal Pharmaceuticals’ resmetirom (the first treatment for NASH with liver fibrosis), Merck’s sotatercept (a treatment for pulmonary arterial hypertension), Lilly’s donanemab for Alzheimer’s disease and Karuna Therapeutics’ drug to treat schizophrenia. Let’s hope 2024 turns out to be an even bigger year for new drug approvals.

Impressions: 4140

https://www.pharmacompass.com/radio-compass-blog/fda-approvals-rise-49-in-2023-crispr-s-gene-editing-therapy-sees-light-of-day

#PharmaFlow by PHARMACOMPASS
01 Feb 2024

NEWS #PharmaBuzz

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Global Sales Information

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US Medicaid Prescriptions

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01

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BOS Manchester
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Company : Biohaven Pharma

Rimegepant Sulfate

Drug Cost (USD) : 478,240,312

Year : 2023

Prescribers : 83811

Prescriptions : 329578

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Company : Biohaven Pharma

Rimegepant Sulfate

Drug Cost (USD) : 276,493,155

Year : 2022

Prescribers : 56513

Prescriptions : 207402

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BOS Manchester
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Company : Biohaven Pharma

Rimegepant Sulfate

Drug Cost (USD) : 118,402,787

Year : 2021

Prescribers : 32315

Prescriptions : 104314

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Company : Biohaven Pharma

Rimegepant Sulfate

Drug Cost (USD) : 18,933,232

Year : 2020

Prescribers : 8957

Prescriptions : 19444

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Annual Reports

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Brand Name : Nurtec ODT/Vydura

Rimegepant Sulfate

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BOS Manchester
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Brand Name : Nurtec ODT/Vydura

U.S.A
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BOS Manchester
Not Confirmed

Rimegepant Sulfate

Main Therapeutic Indication : Neurology

Currency : USD

2022 Revenue in Millions : 213

2021 Revenue in Millions : 0

Growth (%) : 100

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02

Brand Name : Nurtec ODT/Vydura

Rimegepant Sulfate

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BOS Manchester
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Brand Name : Nurtec ODT/Vydura

U.S.A
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BOS Manchester
Not Confirmed

Rimegepant Sulfate

Main Therapeutic Indication : Neurology

Currency : USD

2023 Revenue in Millions : 928

2022 Revenue in Millions : 213

Growth (%) : 336

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Brand Name : Nurtec ODT/Vydura

Rimegepant Sulfate

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BOS Manchester
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Brand Name : Nurtec ODT/Vydura

U.S.A
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Rimegepant Sulfate

Main Therapeutic Indication : Neurology

Currency : USD

2024 Revenue in Millions : 1,263

2023 Revenue in Millions : 928

Growth (%) : 36

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Market Place

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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01

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BOS Manchester
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PFIZER

U.S.A
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RIMEGEPANT SULFATE

US Patent Number : 8759372

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212728

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-02-25

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02

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BOS Manchester
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PFIZER

U.S.A
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BOS Manchester
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RIMEGEPANT SULFATE

US Patent Number : 8314117

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212728

Patent Use Code : U-3142

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-09

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03

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BOS Manchester
Not Confirmed

PFIZER

U.S.A
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BOS Manchester
Not Confirmed

RIMEGEPANT SULFATE

US Patent Number : 8314117

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212728

Patent Use Code : U-2718

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-09

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04

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BOS Manchester
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PFIZER

U.S.A
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BOS Manchester
Not Confirmed

RIMEGEPANT SULFATE

US Patent Number : 11083724

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212728

Patent Use Code : U-3142

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-03-25

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BOS Manchester
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PFIZER

U.S.A
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BOS Manchester
Not Confirmed

RIMEGEPANT SULFATE

US Patent Number : 11083724

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212728

Patent Use Code : U-2718

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-03-25

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Health Canada Patents

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01

Pfizer Canada ULC

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CPhI India
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Pfizer Canada ULC

Country
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CPhI India
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RIMEGEPANT SULFATE

Brand Name : NURTEC ODT

Patent Number : 2777518

Filing Date : 2010-10-13

Strength per Unit : 75mg

Dosage Form : TABLET (ORALLY DISINTEGRATING)

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2030-10-13

Date Granted : 2017-07-04

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Pfizer Canada ULC

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CPhI India
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Pfizer Canada ULC

Country
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CPhI India
Not Confirmed

RIMEGEPANT SULFATE

Brand Name : NURTEC ODT

Patent Number : 2865585

Filing Date : 2013-02-25

Strength per Unit : 75mg

Dosage Form : TABLET (ORALLY DISINTEGRATING)

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2033-02-25

Date Granted : 2019-12-10

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API | Excipient name

Rimegepant Sulfate

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

Rimegepant Sulfate Manufacturers

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.

Rimegepant Sulfate Suppliers

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.

Rimegepant Sulfate USDMF

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.

Rimegepant Sulfate KDMF

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.

Rimegepant Sulfate WC

A Rimegepant Sulfate written confirmation (Rimegepant Sulfate WC) is an official document issued by a regulatory agency to a Rimegepant Sulfate manufacturer, verifying that the manufacturing facility of a Rimegepant Sulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rimegepant Sulfate APIs or Rimegepant Sulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Rimegepant Sulfate WC (written confirmation) as part of the regulatory process.

click here to find a list of Rimegepant Sulfate suppliers with Written Confirmation (WC) on PharmaCompass.

Rimegepant Sulfate 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 Rimegepant Sulfate as an active pharmaceutical ingredient (API).

Finished drug products

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.

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 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.

Compounded drug products

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 GMP

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.

Rimegepant Sulfate CoA

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).

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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