Viewing data from:

GVOKE PFS

NDA

GLUCAGON | N212097 | XERIS PHARMACEUTICALS INC

6 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

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2030

2031

2032

2033

2034

2035

2036

Today

9649364

Apr. 22, 2036

11590205

Apr. 22, 2036

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 DMFs4 inactive

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

BACHEM AGGLUCAGON

DMF 182772005

AMBIOPHARM INCGLUCAGON (SYNTHETIC)

DMF 263262012

BACHEM AGGLUCAGON PHARMA GRADE

DMF 327032018

FRESENIUS KABI IPSUM SRLGLUCAGON

DMF 360172022

NOVO NORDISK ASInactiveGLUCAGON (BULK)

DMF 29611977

DIOSYNTH BVInactiveGLUCAGON

DMF 55461984

BACHEM FINE CHEMICALS INCInactiveGLUCAGON (1-29), HUMAN HCl SALT - TORRANCE AND SAN DIEGO, CA.

DMF 82531989

BACHEM CALIFORNIAInactiveGLUCAGON (1-29), HUMAN

DMF 122971996

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2025	SUPPL -12	View Letter (PDF)
Dec 27, 2023	SUPPL -13	View Letter (PDF)
Aug 24, 2021	SUPPL -7	View Letter (PDF)
Jul 19, 2021	SUPPL -8	View Letter (PDF)
Apr 8, 2020	SUPPL -1	View Letter (PDF)
Sep 11, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#003 — 0.5MG/0.1ML (0.5MG/0.1ML)

RLD

2 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Sep 10, 2019

#004 — 1MG/0.2ML (1MG/0.2ML)

RLD

2 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Sep 10, 2019

#005 — 1MG/0.2ML (1MG/0.2ML)

RLD

1 patent0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Aug 20, 2021

#001 — 0.5MG/0.1ML (0.5MG/0.1ML)

RLD

2 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Sep 10, 2019

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9649364	Apr 22, 2036	—	—	Yes		—
11590205	Apr 22, 2036	—	—	Yes		—

#002 — 1MG/0.2ML (1MG/0.2ML)

RLD

2 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Sep 10, 2019

#006 — 1MG/0.2ML (1MG/0.2ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 14, 2025

Change History (2)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Xeris removed rapid-service (RS) designation from the Gvoke PFS (glucagon) NDA 212097, supplement 006.

Old: Yes

New: No

MODIFIEDtype7/1/2026

Glucagon (Gvoke PFS) discontinued; product type changed from prescription to discontinued status in NDA 212097.

Old: RX

New: DISCN