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GLUCAGEN

NDA

GLUCAGON HYDROCHLORIDE | N020918 | NOVO NORDISK PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition for Fresenius Kabi USA, LLC FDA-2019-P-4962 · 6 docket documents Fresenius Kabi USA, LLC filed this citizen petition on October 24, 2019, requesting that the FDA designate its Glucagon for Injection, approved under 505(b)(2) NDA 201849, as therapeutically equivalent with an AP rating to the reference listed drug GlucaGen, NDA 020918, manufactured by Novo Nordisk.	Other	2019-10-24	Withdrawn	—
Citizen Petition from Cornerstone Regulatory FDA-2007-P-0248 · 6 docket documents Cornerstone Regulatory submitted this citizen petition requesting that the FDA determine whether Eli Lilly's decision to discontinue marketing Glucagon Hydrochloride for Injection (NDA 12-122) was for reasons of safety or effectiveness, and if not, declare the product suitable for submission as an a	Other	2008-05-14	Denied	Cornerstone Regulatory

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

89 trials from ClinicalTrials.gov, 4 active, 68 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
GLP-1 and Hypoglycemia NCT01858896	Early Phase 1	Active	University of Maryland, Baltimore	28	2013-07 → 2026-12
Liver Glycogen and Hypoglycemia in Humans NCT03241706	Phase 1	Active	Jason Winnick	40	2018-08-02 → 2028-05-31
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
To Determine Tolerability to Glucagon Infusion in Obese Subjects NCT02817659	Phase 1	Active	AdventHealth Translational Research Institute	20	2016-11-01 → 2026-12
A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)NCT02012166	Phase 1	Completed	Merck Sharp & Dohme LLC	18	2005-07 → 2005-12
Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)NCT02086227	Phase 1	Completed	Fresenius Kabi USA, LLC	32	2013-05 → 2013-06
GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose NCT01079624	Phase 1	Completed	Uppsala University	15	2006-08 → 2009-11
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge NCT03061227	N/A	Completed	University Hospital Tuebingen	32	2017-02-10 → 2020-04-30
Effects of Exenatide on Motor Function and the Brain NCT03456687	Phase 1	Completed	University of Florida	5	2018-06-05 → 2021-08-25
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia NCT00418288	N/A	Completed	University of Aarhus	10	2007-01 → 2008-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Glucagen (2024)

Total Spending

$3.5M

Total Claims

9,424

Beneficiaries

6,698

Avg Cost/Unit

$315.61

Spending Trend

$20.6M(2019)→$18.2M(2020)→$8.6M(2021)→$5.9M(2022)→$4.9M(2023)→$3.5M(2024)

YoY Change:+7.1%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Glucagen (2024)

Total Spending

$4.8M

Total Claims

22,838

Beneficiaries

21,431

ASP Price

$190.41

Spending Trend

$10.7M(2019)→$8.5M(2020)→$8.0M(2021)→$7.4M(2022)→$5.8M(2023)→$4.8M(2024)

YoY Change:+1.9%

5yr CAGR:-0.4%

HCPCS: J1610 — Injection, glucagon hydrochloride, per 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jul 22, 2021	SUPPL -56	View Letter (PDF)
Mar 12, 2021	SUPPL -54	View Letter (PDF)
Sep 17, 2020	SUPPL -53	View Letter (PDF)
Apr 20, 2018	SUPPL -49	View Letter (PDF)
Dec 15, 2015	SUPPL -43	View Letter (PDF)
Mar 19, 2014	SUPPL -42	View Letter (PDF)
Apr 30, 2013	SUPPL -40	View Letter (PDF)
Jan 17, 2012	SUPPL -34	View Letter (PDF)
Dec 21, 2010	SUPPL -30	View Letter (PDF)
Nov 18, 2005	SUPPL -17	View Letter (PDF)
Dec 29, 2004	SUPPL -12	View Letter (PDF)
Mar 2, 2004	SUPPL -8	View Letter (PDF)
Jul 11, 2002	SUPPL -3	View Letter (PDF)
Jun 22, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

POWDER;INTRAMUSCULAR, INTRAVENOUS | Approved: Jun 22, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Jun 22, 1998