You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 18, 2025

Details for New Drug Application (NDA): 215400


✉ Email this page to a colleague

« Back to Dashboard


NDA 215400 describes BREKIYA (AUTOINJECTOR), which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the BREKIYA (AUTOINJECTOR) profile page.

The generic ingredient in BREKIYA (AUTOINJECTOR) 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 215400
Tradename:BREKIYA (AUTOINJECTOR)
Applicant:Amneal
Ingredient:dihydroergotamine mesylate
Patents:3
Pharmacology for NDA: 215400
Medical Subject Heading (MeSH) Categories for 215400
Analgesics, Non-Narcotic
Dopamine Agonists
Vasoconstrictor Agents
Suppliers and Packaging for NDA: 215400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BREKIYA (AUTOINJECTOR) dihydroergotamine mesylate SOLUTION;SUBCUTANEOUS 215400 NDA Amneal Pharmaceuticals LLC 64896-509 64896-509-02 4 POUCH in 1 CARTON (64896-509-02) / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength1MG/ML
Approval Date:May 14, 2025TE:RLD:Yes
Patent:⤷  Get Started FreePatent Expiration:Feb 26, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Get Started FreePatent Expiration:Feb 26, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Get Started FreePatent Expiration:Feb 26, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF CLUSTER HEADACHES

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links