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Molecule

Ubrogepant

Calcitonin Gene-related Peptide Receptor Antagonist
Available on request
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Ubrogepant is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Ubrogepant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Calcitonin Gene-related Peptide Receptor Antagonist, Calcitonin Gene-related Peptide Receptor Antagonists
US FDA first approval
23 December 2019
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII AD0O8X2QJRCAS 1374248-77-7DrugBank DB15328Q27273878

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.

Source: US FDA prescribing information

Dosing overview

The recommended dose is 50 mg or 100 mg taken orally, as needed. If needed, a second dose may be administered at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. Severe Hepatic or Severe Renal Impairment: Recommended dose is 50 mg, if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose.

Source: US FDA prescribing information

Contraindications

UBRELVY is contraindicated: With concomitant use of strong CYP3A4 inhibitors In patients with a history of serious hypersensitivity to ubrogepant or any component of UBRELVY. Reactions have included anaphylaxis, dyspnea, and facial or throat edema Concomitant use with strong CYP3A4 inhibitors. History of serious hypersensitivity to ubrogepant or any component of UBRELVY.

Source: US FDA prescribing information

Warnings and precautions

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue UBRELVY and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur within minutes, hours, or days after administration. Hypertension: New-onset or worsening of pre-existing hypertension may occur. Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions occurred within hours after dosing and were not serious, and some reactions led to discontinuation.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions Hypertension Raynaud’s Phenomenon The most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence.

Source: US FDA prescribing information

Interactions

Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure. For additional dose modifications for moderate or weak CYP3A4 inhibitors and inducers or BCRP and/or P-gp only inhibitors, refer to section 2.2.

Source: US FDA prescribing information

Storage

Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Ubrogepant, sorted by availability.

MedicineManufacturerRegisterAvailability
Ubrelvy 100 mg tabletOralAllerganUS FDAAvailable on request
Ubrelvy 50 mg tabletOralAllerganUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 23 December 2019Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Ubrogepant available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Ubrogepant and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Ubrogepant have?

The catalogue lists 1 brand names for Ubrogepant, including Ubrelvy.

Is Ubrogepant approved by the US FDA?

Yes. The US FDA first approved Ubrogepant on 23 December 2019, according to Drugs@FDA.

Does Ubrogepant need cold chain shipping?

No listed presentation of Ubrogepant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. UBRELVY prescribing information (Allergan). U.S. National Library of Medicine, DailyMed. Retrieved 5 June 2025

Request Ubrogepant for export supply

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