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UBROGEPANT
CAS NO.: 1374248-77-7
Chemical Formula: C29H26F3N5O3
Molecular Weight: 549.5000
DMF&GMP status: Please contact us for more details.
Description:
Ubrogepant is indicated for the acute treatment of migraine headaches with or without aura in adults. It was approved by the FDA on December 23, 2019, and is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine. Several oral small molecule CGRP receptor antagonists, belonging to a class of medications referred to as "gepants", have been investigated for migraines, but only ubrogepant and [rimegepant] remain in clinical development. Previous agents within this class were efficacious but limited by liver toxicity - this led to the development of ubrogepant, which was designed to be a hepatoxicity-free alternative to its predecessors. Several parenteral monoclonal antibodies acting against the CGRP pathway (e.g. [erenumab], [fremanezumab], [galcanezumab]) have also been approved in recent years. Compared to the current standard of therapy for migraine treatment, namely triptans such as [sumatriptan] and [almotriptan], CGRP antagonists present several advantages. They appear to be better tolerated, do not contribute to medication overuse headaches, and carry no apparent cardiovascular risk, making them suitable for use in patients with cardiovascular disease. The development of oral gepants, including ubrogepant, may therefore constitute a significant advance in migraine headache treatment and may become the new standard of therapy in the treatment of this debilitating condition.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
UBROGEPANTTABLET;ORAL50MGUBRELVYALLERGAN SALES LLC
UBROGEPANTTABLET;ORAL100MGUBRELVYALLERGAN SALES LLC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
875409607/19/2032DSDPU-2717
891221011/10/2031DSDP
949954511/10/2031DSDPU-2718
983344811/10/2031U-2718
1011783601/30/2035DP
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 12/23/2024