GLUCAGON - Generic Drug Details

What are the generic sources for glucagon and what is the scope of freedom to operate?

Glucagon is the generic ingredient in six branded drugs marketed by Amphastar Pharms Inc, Lilly, Xeris, Novo Nordisk, and Fresenius Kabi Usa, and is included in seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glucagon has one hundred and four patent family members in forty-two countries.

There are twelve drug master file entries for glucagon. Four suppliers are listed for this compound.

Summary for GLUCAGON

International Patents:	104
US Patents:	5
Tradenames:	6
Applicants:	5
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	809
Patent Applications:	7,015
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for GLUCAGON
What excipients (inactive ingredients) are in GLUCAGON?	GLUCAGON excipients list
DailyMed Link:	GLUCAGON at DailyMed

See drug prices for GLUCAGON

Recent Clinical Trials for GLUCAGON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 3
Neurobiology Research Unit	Phase 2
Amir Moheet	Phase 2/Phase 3

See all GLUCAGON clinical trials

Pharmacology for GLUCAGON

Drug Class	Antihypoglycemic Agent Gastrointestinal Motility Inhibitor
Physiological Effect	Decreased GI Motility Decreased GI Smooth Muscle Tone Decreased Glycolysis Increased Gluconeogenesis Increased Glycogenolysis

Medical Subject Heading (MeSH) Categories for GLUCAGON

Gastrointestinal Agents

Hormones

US Patents and Regulatory Information for GLUCAGON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xeris	GVOKE KIT	glucagon	SOLUTION;SUBCUTANEOUS	212097-005	Aug 20, 2021		RX	Yes	Yes			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-001	Sep 10, 2019		DISCN	Yes	No			Y

Expired US Patents for GLUCAGON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019

EU/EMA Drug Approvals for GLUCAGON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Tetris Pharma B.V	Ogluo	glucagon	EMEA/H/C/005391 Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.	Authorised	no	no	no	2021-02-11
Eli Lilly Nederland B.V.	Baqsimi	glucagon	EMEA/H/C/003848 Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.	Authorised	no	no	no	2019-12-16

International Patents for GLUCAGON

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201890704	СПОСОБЫ ПОЛУЧЕНИЯ СТАБИЛЬНЫХ ТЕРАПЕВТИЧЕСКИХ СОСТАВОВ В АПРОТОННЫХ ПОЛЯРНЫХ РАСТВОРИТЕЛЯХ
World Intellectual Property Organization (WIPO)	2017053922
Japan	6835831
South Korea	20180054847	양극성 용매에서 안정한 치료 제형들의 제조방법.
World Intellectual Property Organization (WIPO)	2016201248
European Patent Office	3258919	FORMULATION DE POUDRE NASALE POUR LE TRAITEMENT DE L'HYPOGLYCÉMIE (NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA)