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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 213436


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NDA 213436 describes TRUDHESA, which is a drug marketed by Impel Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the TRUDHESA profile page.

The generic ingredient in TRUDHESA is dihydroergotamine mesylate. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 213436
Tradename:TRUDHESA
Applicant:Impel Pharms
Ingredient:dihydroergotamine mesylate
Patents:6
Pharmacology for NDA: 213436
Medical Subject Heading (MeSH) Categories for 213436
Analgesics, Non-Narcotic
Dopamine Agonists
Vasoconstrictor Agents
Suppliers and Packaging for NDA: 213436
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRUDHESA dihydroergotamine mesylate SPRAY, METERED;NASAL 213436 NDA Impel Pharmaceuticals LLC 77530-725 77530-725-00 1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS
TRUDHESA dihydroergotamine mesylate SPRAY, METERED;NASAL 213436 NDA Impel Pharmaceuticals LLC 77530-725 77530-725-04 4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.725MG/SPRAY
Approval Date:Sep 2, 2021TE:RLD:Yes
Patent:⤷  Get Started FreePatent Expiration:Dec 25, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Get Started FreePatent Expiration:Jan 23, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Get Started FreePatent Expiration:Jan 4, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION OF DIHYDROERGOTAMINE MESYLATE BY METERED SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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