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

2029

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

96 trials from ClinicalTrials.gov — 5 recruiting, 5 active, 69 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Determine Tolerability to Glucagon Infusion in Obese Subjects NCT02817659	Phase 1	Active	AdventHealth Translational Research Institute	20	2016-11-01 → 2026-12
Optimization of Obesity for Total Knee Replacement With Glucagon-like Peptide-1 Receptor Agonist NCT06807970	Early Phase 1	Active	The University of Hong Kong	54	2025-09-01 → 2028-07-01
GLP-1 and Hypoglycemia NCT01858896	Early Phase 1	Active	University of Maryland, Baltimore	28	2013-07 → 2026-12
Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects NCT03139305	Phase 1	Active	AdventHealth Translational Research Institute	30	2017-10-24 → 2027-02
Liver Glycogen and Hypoglycemia in Humans NCT03241706	Phase 1	Active	Jason Winnick	40	2018-08-02 → 2028-05-31
Studies of Insulin and Glucagon Action in the Liver NCT07300982	Phase 1/2	Not Yet Recruiting	Duke University	40	2026-10 → 2029-12
Semaglutide in Youth With Autism Spectrum Disorder NCT07770152	Phase 4	Not Yet Recruiting	Children's Hospital Medical Center, Cincinnati	42	2026-09-01 → 2029-09-01
Combination Therapy for Alcohol Use Disorder NCT07249554	Phase 2	Not Yet Recruiting	Johns Hopkins University	45	2026-09 → 2028-09
The Postprandial Hypo-Avoid Study NCT07427251	Phase 4	Recruiting	Steno Diabetes Center Copenhagen	18	2026-04-27 → 2028-05-01
Fibrosis Lessens After Metabolic Surgery NCT06374875	Phase 4	Recruiting	The Cleveland Clinic	120	2024-07-11 → 2029-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 6 NDCs

Highest NADAC/Unit

$3203.28

per ml

Lowest NADAC/Unit

$1600.23

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72065012012GVOKE HYPOPEN 2PK 0.5 MG/0.1 ML	$3203.28	ML	Brand	—	2026-08-19
72065013112GVOKE PFS 2-PK 1 MG/0.2 ML SYR	$1606.19	ML	Brand	—	2026-08-19
72065012111GVOKE HYPOPEN 1-PK 1 MG/0.2 ML	$1603.46	ML	Brand	—	2026-08-19
72065012112GVOKE HYPOPEN 2-PK 1 MG/0.2 ML	$1603.35	ML	Brand	—	2026-08-19
72065014011GVOKE 1 MG/0.2 ML KIT	$1600.99	ML	Brand	—	2026-08-19
72065013111GVOKE PFS 1-PK 1 MG/0.2 ML SYR	$1600.23	ML	Brand	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (8 FSS)

Lowest Price

$73.52

Highest Price

$735.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72065-0120-12GVOKE HYPOPEN	$479.79	FSS	Xeris Pharmaceutical, Inc.	04/01/2026
72065-0121-11GVOKE HYPOPEN	$239.44	FSS	Xeris Pharmaceutical, Inc.	04/01/2026
72065-0121-12GVOKE HYPOPEN	$479.32	FSS	Xeris Pharmaceutical, Inc.	04/01/2026
72065-0131-11GVOKE SYRINGE	$239.15	FSS	Xeris Pharmaceutical, Inc.	04/01/2026
72065-0131-12GVOKE SYRINGE	$478.81	FSS	Xeris Pharmaceutical, Inc.	04/01/2026
72065-0140-11GVOKE KIT	$239.57	FSS	Xeris Pharmaceutical, Inc.	04/01/2026
00517-2901-01GVOKE 1MG/0.2ML INJ	$73.52	FSS	American Regent, Inc.	09/28/2028
00517-2901-10GVOKE 1MG/0.2ML INJ	$735.18	FSS	American Regent, Inc.	09/28/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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) · 2 use codes

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