Orange Book drug · Brand (NDA)

Brekiya (autoinjector)

Dihydroergotamine Mesylate

RLDNDA 215400 Amneal

Approved

May 14, 2025

Strengths

Listed patents

What does the FDA Orange Book show for Brekiya (autoinjector)?

Brekiya (autoinjector) contains Dihydroergotamine Mesylate and is the new drug FDA Orange Book record for NDA 215400. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application: NDA 215400
Application holder: Amneal Pharmaceuticals LLC
Product presentations: 1
Marketing categories: Prescription
Reference roles: RLD / RS
TE codes: None posted
Listed patents: 8
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

FDA product-presentation matrix

Every product number in this exact application

Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	1MG/ML	SOLUTIONSUBCUTANEOUS	Prescription	None posted	RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Amneal Pharmaceuticals LLC

The Orange Book identifies this organization as the applicant responsible for NDA 215400.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not

FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

8 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Aug 24, 2039. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

13 other ANDAs and 4 other NDAs found

9 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 215400 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Subcutaneous

Dihydroergotamine Mesylate

1 application

Product rows: 1
Active applications: 1
Active with AB row: 0

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-215400

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 215400

RLDRS

Strength: 1MG/ML
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
May 14, 2025
1 yr 3 mo ago
Today
Patent 10532049 expires
Listed drug product patent expiration.
Feb 26, 2039
in 12 yr 9 mo
Patent 11304942 expires
Listed drug product patent expiration.
Feb 26, 2039
in 12 yr 9 mo
Patent 11819501 expires
Listed method-of-use patent (U-848) expiration.
Feb 26, 2039
in 12 yr 9 mo
Patent 11819501 expires
Listed method-of-use patent (U-4188) expiration.
Feb 26, 2039
in 12 yr 9 mo
Patent 12533351 expires
Listed drug product patent expiration.
Feb 26, 2039
in 12 yr 9 mo
Patent 11541043 expires
Listed drug product patent expiration.
Mar 20, 2039
in 12 yr 10 mo
Patent 12329749 expires
Listed drug product patent expiration.
May 27, 2039
in 13 yr
Patent 12329749 expires
Listed drug product patent expiration.
May 27, 2039
in 13 yr
Patent 11083712 expires
Listed drug product patent expiration.
Jun 30, 2039
in 13 yr 1 mo
Patent 11083712 expires
Listed drug product patent expiration.
Jun 30, 2039
in 13 yr 1 mo
Patent 12414941 expires
Listed drug product patent expiration.
Aug 24, 2039
in 13 yr 3 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DIHYDROERGOTAMINE MESYLATE

Strength

1MG/ML

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 215400

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10532049	Feb 26, 2039	in 12 yr 9 mo	Product
11304942	Feb 26, 2039	in 12 yr 9 mo	Product
11819501	Feb 26, 2039	in 12 yr 9 mo	U-848
11819501	Feb 26, 2039	in 12 yr 9 mo	U-4188
12533351	Feb 26, 2039	in 12 yr 9 mo	Product
11541043	Mar 20, 2039	in 12 yr 10 mo	Product
12329749	May 27, 2039	in 13 yr	ProductU-2718
12329749	May 27, 2039	in 13 yr	ProductU-4508
11083712	Jun 30, 2039	in 13 yr 1 mo	ProductU-2718
11083712	Jun 30, 2039	in 13 yr 1 mo	ProductU-4508
12414941	Aug 24, 2039	in 13 yr 3 mo	Product

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Dihydroergotamine Mesylate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.