BAQSIMI Drug Patent Profile

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

Baqsimi is a drug marketed by Amphastar Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-three patent family members in forty-one countries.

The generic ingredient in BAQSIMI 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 Baqsimi

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

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Summary for BAQSIMI

International Patents:	83
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
Drug Prices:	Drug price information for BAQSIMI
What excipients (inactive ingredients) are in BAQSIMI?	BAQSIMI excipients list
DailyMed Link:	BAQSIMI at DailyMed

Drug patent expirations by year for BAQSIMI

Recent Clinical Trials for BAQSIMI

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

Sponsor	Phase
Eli Lilly and Company	Phase 1
Azienda Ospedaliera Città della Salute e della Scienza di Torino	Phase 4

See all BAQSIMI clinical trials

Pharmacology for BAQSIMI

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 BAQSIMI

BAQSIMI is protected by three US patents.

Patents protecting BAQSIMI

Nasal powder formulation for treatment of hypoglycemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEVERE HYPOGLYCEMIA IN PATIENTS WITH DIABETES

Medication delivery systems and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Device for dispensing a fluid product
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Patent Expiration: ⤷ Sign Up

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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
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 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 BAQSIMI

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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 BAQSIMI

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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 BAQSIMI

See the table below for patents covering BAQSIMI around the world.

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Country	Patent Number	Title	Estimated Expiration
Peru	20171334	FORMULACION EN POLVO NASAL PARA EL TRATAMIENTO DE HIPOGLICEMIA	⤷ Sign Up
France	3052691	DISPOSITIF DE DISTRIBUTION DE PRODUIT FLUIDE.	⤷ Sign Up
European Patent Office	3258919	FORMULATION DE POUDRE NASALE POUR LE TRAITEMENT DE L'HYPOGLYCÉMIE (NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA)	⤷ Sign Up
Australia	3849402		⤷ Sign Up
Japan	6899429		⤷ Sign Up
European Patent Office	3946427	SYSTÈMES ET PROCÉDÉS D'ADMINISTRATION DE MÉDICAMENT (MEDICATION DELIVERY SYSTEMS AND METHODS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016133863		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration