Viewing data from:

BREKIYA (AUTOINJECTOR)

NDA

DIHYDROERGOTAMINE MESYLATE | N215400 | AMNEAL PHARMACEUTICALS LLC

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2026

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Today

Feb. 26, 2039

Jun. 30, 2039

Feb. 26, 2039

Mar. 20, 2039

Feb. 26, 2039

May. 27, 2039

Aug. 24, 2039

Feb. 26, 2039

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVDIHYDROERGOTAMINE MESYLATE

DMF 149442000

CURIA ITALY SRLDIHYDROERGOTAMINE MESYLATE USP/EP

DMF 224072009

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 304972016

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 330222018

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIHYDROERGOTAMINE MESYLATE

DMF 102421993

LEK PHARMACEUTICALS DDInactiveDIHYDROERGOTAMINE MESYLATE

DMF 161942002

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 23, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

RLD

8 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: May 14, 2025

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10532049	Feb 26, 2039	—	—	Yes	—	—
11083712	Jun 30, 2039	—	—	Yes		—
11304942	Feb 26, 2039	—	—	Yes	—	—
11541043	Mar 20, 2039	—	—	Yes	—	—
11819501	Feb 26, 2039	—	—	—		—
12329749	May 27, 2039	—	—	Yes		—
12414941	Aug 24, 2039	—	—	Yes	—	—
12533351	Feb 26, 2039	—	—	Yes	—	—

Change History (4)

Recent changes detected for this application.

ADDED7/1/2026

Amneal added U.S. Patent 11,083,712 to the Orange Book listing for Brekiya (dihydroergotamine mesylate autoinjector), NDA 215400.

New: New record

ADDED7/1/2026

Amneal added U.S. Patent 12,329,749 to the Orange Book for Brekiya (dihydroergotamine mesylate) autoinjector, NDA 215400.

New: New record

ADDED7/1/2026

Amneal added patent 12,414,941 to the Orange Book for Brekiya (dihydroergotamine mesylate autoinjector), NDA 215400.

New: New record

ADDED7/1/2026

Amneal added U.S. Patent 11,541,043 to the Orange Book for Brekiya (dihydroergotamine mesylate autoinjector), NDA 215400.

New: New record