GVOKE PFS Drug Patent Profile

When do Gvoke Pfs patents expire, and when can generic versions of Gvoke Pfs launch?

Gvoke Pfs is a drug marketed by Xeris and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-four patent family members in fifteen countries.

The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glucagon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gvoke Pfs

A generic version of GVOKE PFS was approved as glucagon by FRESENIUS KABI USA on May 8^th, 2015.

Summary for GVOKE PFS

International Patents:	24
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Drug Prices:	Drug price information for GVOKE PFS
What excipients (inactive ingredients) are in GVOKE PFS?	GVOKE PFS excipients list
DailyMed Link:	GVOKE PFS at DailyMed

See drug prices for GVOKE PFS

Pharmacology for GVOKE PFS

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

US Patents and Regulatory Information for GVOKE PFS

GVOKE PFS is protected by two US patents.

Patents protecting GVOKE PFS

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	212097-001	Sep 10, 2019		DISCN	Yes	No			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-001	Sep 10, 2019		DISCN	Yes	No			Y
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097-002	Sep 10, 2019		RX	Yes	Yes			Y

EU/EMA Drug Approvals for GVOKE PFS

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 GVOKE PFS

See the table below for patents covering GVOKE PFS around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6835831
Australia	2016326749	Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
World Intellectual Property Organization (WIPO)	2016201248
Mexico	2018003705	METODOS PARA PRODUCIR FORMULACIONES DE GLUCAGON TERAPEUTICAS ESTABLES EN SOLVENTES POLARES APROTICOS. (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS.)
South Africa	201801912	METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS
China	115531523	在非质子极性溶剂中制备稳定的普兰林肽治疗制剂的方法 (Method for preparing stable pramlintide therapeutic formulations in aprotic polar solvents)