BAQSIMI Drug Patent Profile

Name: BAQSIMI Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 patent family members in forty countries.

The generic ingredient in BAQSIMI is glucagon. There are twelve drug master file entries for this compound. Eight 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:	80
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 and one FDA Regulatory Exclusivity.

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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	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
>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	⤷ Start Trial	⤷ Start Trial
>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/005391Ogluo 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/003848Baqsimi 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
Australia	2016220235		⤷ Start Trial
Australia	2021203035		⤷ Start Trial
Brazil	112017014994		⤷ Start Trial
Canada	2975562		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BAQSIMI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2875043	301294	Netherlands	⤷ Start Trial	PRODUCT NAME: DASIGLUCAGON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, ZOALS DASIGLUCAGON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
2875043	CR 2024 00043	Denmark	⤷ Start Trial	PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725
2875043	122024000057	Germany	⤷ Start Trial	PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
2875043	24C1043	France	⤷ Start Trial	PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

DrugChatter Q&A for BAQSIMI

Can baqsimi be stored at room temperature?
Does baqsimi work if the person is unconscious?