Orange Book drug · Brand (NDA)

Zegalogue (autoinjector)

Dasiglucagon Hydrochloride

DiscontinuedRLDNDA 214231 Zealand Pharma

Approved

Mar 22, 2021

Strengths

Listed patents

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

Zegalogue (autoinjector) contains Dasiglucagon Hydrochloride and is the new drug FDA Orange Book record for NDA 214231. 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 214231
Application holder: Zealand Pharma US Inc
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 2
Exclusivity records: 1

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
002	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTIONSUBCUTANEOUS	Discontinued	None posted	RLD

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

Zealand Pharma US Inc

The Orange Book identifies this organization as the applicant responsible for NDA 214231.

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 on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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

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

The latest future date recorded across those files is Mar 22, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 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 214231 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

Dasiglucagon Hydrochloride

1 application

Product rows: 2
Active applications: 0
Active with AB row: 0

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-214231

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 214231

RLDDiscontinued

Strength: EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Mar 22, 2021
5 yr 5 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 22, 2026
4 mo ago
Today
Patent 11795204 expires
Listed method-of-use patent (U-3752) expiration.
Jan 06, 2034
in 7 yr 7 mo
Patent 10442847 expires
Listed drug substance patent expiration.
Mar 22, 2035
in 8 yr 9 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DASIGLUCAGON HYDROCHLORIDE

Strength

EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 214231

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Marketing exclusivity

Hatch-Waxman

NCENew chemical entity exclusivity (5 years)
Mar 22, 2026
4 mo ago

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
11795204	Jan 06, 2034	in 7 yr 7 mo	U-3752
10442847	Mar 22, 2035	in 8 yr 9 mo	SubstanceProduct

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.

No other applications share this active ingredient.

View full Dasiglucagon Hydrochloride 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.