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GLUCAGON

NDA

GLUCAGON HYDROCHLORIDE | N012122 | ELI LILLY AND CO

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Physicians Committee for Responsible Medicine FDA-2023-P-2507 · 30 docket documents The Physicians Committee for Responsible Medicine filed this citizen petition requesting that the Food and Drug Administration Commissioner require manufacturers of glucagon-like peptide-1 receptor agonists, including semaglutide, to include labeling disclosing that low-fat plant-based diets have co	Other	2023-06-21	Open	Physicians Committee for Responsible Medicine
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.

Products (2)

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#001 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982