BAQSIMI Drug Patent Profile

When do Baqsimi patents expire, and what generic alternatives are available?

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

This drug has seventy-eight 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.

Summary for BAQSIMI

International Patents:	78
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

See drug prices 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 two US patents.

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

Expired US Patents for BAQSIMI

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 BAQSIMI

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

International Patents for BAQSIMI

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

Country	Patent Number	Title	Estimated Expiration
Japan	6522144
Japan	2019521050	流体製品吐出装置
Hungary	E049413
China	1240482

Supplementary Protection Certificates for BAQSIMI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2875043	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
2875043	24C1043	France		PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
2875043	CR 2024 00043	Denmark		PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725
2875043	2490313-0	Sweden		PRODUCT NAME: DASIGLUCAGON OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, SUCH AS DASIGLUCAGON HYDROCHLORIDE; REG. NO/DATE: EU/1/24/1829 20240724

Market Dynamics and Financial Trajectory of BAQSIMI

Last updated: July 27, 2025

Introduction

BAQSIMI (glucagon) represents a significant advancement within emergency medical treatment for severe hypoglycemia, particularly among individuals with diabetes. As a nasal powder formulation of glucagon, BAQSIMI offers a needle-free, rapid-acting option, addressing critical gaps in timely intervention. Understanding its market dynamics and financial journey is essential for stakeholders evaluating its growth potential and strategic positioning within the rapidly expanding diabetes drug landscape.

Product Overview: BAQSIMI

BAQSIMI, developed by Eli Lilly and Company, is a prescription nasal glucagon designed for immediate administration in cases of severe hypoglycemia where the patient is unable to consume oral carbohydrates. Approved by the FDA in 2019, BAQSIMI's unique nasal delivery system enhances ease of use, particularly for laypersons and caregivers, reducing barriers associated with traditional injectable glucagon kits.

The product aligns with a broader shift towards user-friendly drug delivery systems and personalized emergency medications. Its portability, rapid absorption, and needle-free administration have positioned BAQSIMI as a preferred alternative in hypoglycemia management.

Market Dynamics

1. Growing Prevalence of Diabetes and Hypoglycemia Incidents

The global diabetes epidemic propels demand for effective hypoglycemia treatments. The International Diabetes Federation estimates approximately 536 million adults worldwide with diabetes, expected to reach 783 million by 2045 [1]. Severe hypoglycemic episodes occur in roughly 2-4% of individuals with type 1 and type 2 diabetes annually, often requiring emergency intervention [2].

This burgeoning patient population inherently drives demand for swift, reliable glucagon formulations like BAQSIMI. Increased awareness campaigns and updated clinical guidelines emphasizing hypoglycemia management further bolster market interest.

2. Competitive Landscape and Product Differentiation

While traditional injectable glucagon kits (e.g., GlucaGen) have been standard, the introduction of nasal formulations like BAQSIMI marks a paradigm shift. Other nasal glucagon products, such as Glucagon Nasal Powder (marketed by Novo Nordisk as Gvoke Nasal), compete on similar attributes but differ in branding, dosing, and distribution strategies.

BAQSIMI’s advantages include rapid administration (within seconds), portability, non-reliance on reconstitution, and minimal training requirements. These differentiators help capture market share from injectable counterparts and appeal to lay caregivers and emergency responders.

3. Regulatory and Reimbursement Factors

Since its FDA approval in 2019, BAQSIMI has secured coverage through major insurance providers, including Medicaid, Medicare, and commercial plans, bolstering accessibility. Continued expansion of reimbursement clauses and inclusion in emergency drug formularies will influence its adoption rates.

Regulatory approvals outside the U.S., such as in Europe and Asia Pacific, will be vital for global growth. Countries with high diabetes prevalence and established healthcare infrastructure are key targets, fostering international market expansion.

4. Distribution Channels and Strategic Partnerships

Eli Lilly’s strategic partnerships with pharmacy chains and healthcare providers facilitate widespread availability. The product's OTC status in some regions expedites in-home and community access. Ongoing collaborations with diabetes advocacy groups and medical professionals enhance educational outreach, impacting prescribing patterns.

5. Pricing and Market Penetration Strategy

Pricing strategies balance affordability with profit margins. BAQSIMI's premium pricing reflects its innovation status. Market penetration depends on insurance coverage, physician endorsement, and patient acceptance of nasal delivery. The company's marketing efforts aim to convert clinicians from injectable glucagon to nasal alternatives.

Financial Trajectory

1. Revenue Growth and Sales Trends

Since its launch, BAQSIMI has exhibited steady revenue growth, aligning with the upward trajectory of diabetes management markets. From initial post-launch sales estimates, Eli Lilly reported a multi-million-dollar sales figure in 2021, with projections indicating significant acceleration as awareness and diagnoses increase [3].

Sales are influenced by factors like market introduction speed in various geographies, reimbursement policies, and competitive dynamics. The product's innovation-driven positioning has justified premium pricing, translating into higher revenue per unit sold relative to older formulations.

2. Market Adoption and Forecasts

Analyst forecasts predict a compound annual growth rate (CAGR) of approximately 10-15% over the next five years, driven by rising diabetes prevalence and increased emergency preparedness. Continued innovation, such as combination therapies or expanded indications, may further invigorate sales.

Eli Lilly’s substantial R&D investment in diabetes care and strategic marketing initiatives are expected to reinforce its market presence. The company’s vaccine and insulin portfolio integration could also lead to cross-promotional opportunities.

3. Challenges and Risks

Barriers include pricing pressures, regulatory hurdles outside the U.S., and competition from oral or implantable alternatives. Moreover, the stigma or reluctance around taking emergency medications could limit consumer uptake. Supply chain disruptions or manufacturing setbacks may temporarily affect financial performance.

Future Outlook and Strategic Considerations

The financial outlook for BAQSIMI remains positive, contingent upon expanding global acceptance and optimizing distribution channels. Emphasizing patient education on the importance of hypoglycemia management and clinician endorsement will further increase product adoption.

Eli Lilly’s pipeline innovation, coupled with strategic collaborations, could unlock additional revenue streams, such as expanded indications for other nasal or non-injectable therapies.

Key Takeaways

• The expanding diabetes population and need for user-friendly hypoglycemia treatments favor BAQSIMI’s market growth.
• Its nasal, needle-free delivery offers a competitive edge over traditional injectable glucagon, enhancing patient and caregiver compliance.
• Market penetration depends heavily on insurance reimbursement, clinical endorsement, and geographic expansion, with emerging markets representing growth opportunities.
• Financial trajectories suggest steady growth with potential acceleration as awareness and adoption increase in tandem with diabetes diagnosis rates.
• Risks include pricing pressures, competition, and regulatory hurdles; strategic marketing and innovation are crucial to sustaining growth.

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FAQs

Q1: How does BAQSIMI compare with traditional injectable glucagon in terms of efficacy?

A1: Clinical trials demonstrate that BAQSIMI’s nasal glucagon is comparable in efficacy to injectable formulations for severe hypoglycemia, with rapid absorption and prompt glucose elevation [4].

Q2: What are the main advantages of BAQSIMI’s nasal delivery system?

A2: The nasal powder formulation offers needle-free administration, quick onset of action, ease of use without reconstitution, and enhanced portability—beneficial in emergency scenarios.

Q3: What are the primary barriers to broader adoption of BAQSIMI?

A3: Barriers include high cost, limited awareness among laypersons, insurance reimbursement complexities, and the persistence of traditional injectable options.

Q4: Are there any expanded indications for BAQSIMI beyond hypoglycemia management?

A4: Currently, BAQSIMI is specifically approved for severe hypoglycemia. Future research may explore broader applications, but none are approved at present.

Q5: What strategies might Eli Lilly employ to enhance BAQSIMI’s market share?

A5: Strategies include expanding global regulatory approvals, broadening insurance coverage, patient education initiatives, strategic partnerships, and ongoing clinical development.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
[2] Cryer PE. Severe hypoglycemia in diabetes: risk factors and prevention. Endocrinol Metab Clin North Am. 2019;48(2):269-282.
[3] Eli Lilly and Company. Quarterly Earnings Report, 2022.
[4] Sherr J, et al. A Randomized Clinical Trial Comparing Nasal Glucagon and Injectable Glucagon in Diabetic Patients. Diabetes Care. 2020;43(10):2502-2508.