Glucagon - Generic Drug Details

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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 seven 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:	107
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:	823
Patent Applications:	7,015
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
Pichamol Jirapinyo, MD, MPH	Phase 4
National Center for Advancing Translational Sciences (NCATS)	Early Phase 1
Ain Shams University	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for glucagon

H04AA	Glycogenolytic hormones
H04A	GLYCOGENOLYTIC HORMONES
H04	PANCREATIC HORMONES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for glucagon

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amphastar Pharms Inc	GLUCAGON	glucagon	INJECTABLE;INJECTION	208086-001	Dec 28, 2020		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for glucagon

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

EU/EMA Drug Approvals for glucagon

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for glucagon

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Country	Patent Number	Title	Estimated Expiration
China	108135980	在非质子极性溶剂中制备稳定的胰高血糖素治疗制剂的方法 (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS)	⤷ Sign Up
El Salvador	2017005515	FORMULACIONES DE POLVO NASAL PARA EL TRATAMIENTO DE LA HIPOGLICEMIA	⤷ Sign Up
Canada	3204984	METHODES DE PRODUCTION DE FORMULATIONS THERAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC FORMULATIONS IN APROTIC POLAR SOLVENTS)	⤷ Sign Up
Canada	2999404	METHODES DE PRODUCTION DE FORMULATIONS THERAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC FORMULATIONS IN APROTI C POLAR SOLVENTS)	⤷ Sign Up
Lithuania	3258919		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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