X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
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 Product Name: Vydura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biohaven Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including NURTEC® ODT (rimegepant), to address needs of millions of migraine patients worldwide.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition October 03, 2022
Details:
Results from long-term studies of Nurtec ODT (Rimegepant Sulfate) as a preventive and acute treatment of migraine showed more than 80% of patients achieved ≥50% reduction in moderate or severe monthly migraine days and approximately half experienced a 100% reduction.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
Pfizer will acquire Biohaven, the maker of NURTEC® ODT (rimegepant sulfate). Pfizer will commercialize NURTEC® ODT, an innovative compound for the prevention and acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition May 10, 2022
Details:
Results from the Phase 3 study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to placebo.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Results demonstrate a clinically meaningful reduction in opioid use of Nurtec® ODT (rimegepant) for patient population and may be of benefit to those reliant on opioids to manage their disease, thereby alleviating potential negative consequences of opioid use.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
The results of the study showed that the excretion of Nurtec (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, into human milk is very low and rimegepant was safe and well tolerated by lactating women.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
The CHMP of the EMA adopted a positive opinion for rimegepant, a CGRP receptor antagonist and, will now be reviewed by the European Commission, whose EU trade name will be VYDURA and it will be valid in all 27 EU member states for the treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Vydura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
Nurtec ODT, oral calcitonin-gene related peptide receptor antagonist currently approved for the acute and preventive treatment of migraine. Prior research has implicated CGRP in pathophysiology of disease and suggested therapeutic benefits of CGRP antagonism.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Nurtec ODT
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: BHV-3000
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of regulatory approvals and the satisfaction of other customary conditions and BHVN shares have been issued to Pfizer.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $1,240.0 million Upfront Cash: $500.0 million
Deal Type: Collaboration January 05, 2022
Details:
Rimegepant, commercialized as NURTEC ODT in the U.S., is the first and only oral CGRP (calcitonin gene-related peptide) receptor antagonist for the acute and preventive treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
NURTEC ODT is the first and only calcitonin gene-related peptide receptor antagonist available in a fast-acting orally disintegrating tablet (ODT) approved for the acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
Rimegepant, commercialized as Nurtec® ODT in the U.S., is the first and only oral CGRP (calcitonin gene-related peptide) receptor antagonist for the acute and preventive treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $1,240.0 million Upfront Cash: $500.0 million
Deal Type: Collaboration November 09, 2021
Details:
Efficacy and safety results from the pivotal Phase 2/3 clinical trial of rimegepant for the preventive treatment for migraine will be presented including data showing a rapid reduction in migraine days.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
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 in adults.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2021
Details:
BHV3000-310 is a double-blind, randomized trial evaluating the safety and efficacy of rimegepant in the acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biohaven Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
NURTEC ODT 75 mg, in placebo-controlled trials, helped to return patients to normal functioning within 60 minutes when used in the acute treatment of migraine and has also been shown to reduce monthly migraine days at the same dose.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
Biohaven will use the proceeds for the development, promotion, and commercial launch of NURTEC ODT, as well as for general corporate purposes of the Company and its subsidiaries.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sixth Street
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing August 07, 2020
Details:
Key presentations, including new analyses, highlight NURTEC clinical benefits including rapid and sustained efficacy with a single dose, low rescue medication use, long-term safety in patients with cardiovascular risk factors and concomitant preventive migraine medications.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2020
Details:
Data spotlights NURTEC as the first and only CGRP-targeting agent using a quick-dissolve ODT technology for fast onset of action, return to normal function within one hour and sustained efficacy for 48 hours after a single dose.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
Biohaven and Genpharm's agreement will bring NURTEC™ ODT, the first oral, quick-dissolve, calcitonin gene related peptide antagonist to patients in the Middle East and the Gulf Region.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genpharm Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 27, 2020
Details:
Biohaven and Medison Pharma's partnership will bring NURTEC ODT, the first oral, quick-dissolve, calcitonin gene related peptide (CGRP) antagonist to patients in Israel.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Medison Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 16, 2020
Details:
The collaboration seeks to facilitate telemedicine evaluation for migraine sufferers while patients are increasingly looking to remote evaluations.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biohaven Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 07, 2020
Details:
Rimegepant 75 mg, dosed every other day, demonstrates statistically significant superiority, compared to placebo, on the primary endpoint of reduction in the mean number of migraine days per month.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Product Name: Nurtec ODT
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
