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ZEGALOGUE

NDA

DASIGLUCAGON HYDROCHLORIDE | N214231 | ZEALAND PHARMA US INC

2 strengths2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

10442847

Mar. 22, 2035

11795204

Jan. 6, 2034

NCE

Mar. 22, 2026

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -4	View Letter (PDF)
Mar 23, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)

RLD

2 patents1 exclusivity▴

SOLUTION;SUBCUTANEOUS | Approved: Mar 22, 2021

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10442847	Mar 22, 2035	—	Yes	Yes	—	—
11795204	Jan 6, 2034	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Mar 22, 2026	Expired

#002 — EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)

RLD

2 patents1 exclusivity▾

SOLUTION;SUBCUTANEOUS | Approved: Mar 22, 2021

Change History (2)

Recent changes detected for this application.

MODIFIEDPatent Expiration7/1/2026

Zegalogue (dasiglucagon hydrochloride) Orange Book patent 10,442,847 expiration date extended from Feb 3, 2035 to Mar 22, 2035.

Old: Feb 3, 2035

New: Mar 22, 2035

MODIFIEDPatent Expiration7/1/2026

ZEGALOGUE (dasiglucagon hydrochloride) patent 10,442,847 listed in NDA 214231 has an updated expiration date of Mar 22, 2035, extended from Feb 3, 2035.

Old: Feb 3, 2035

New: Mar 22, 2035