BAQSIMI Drug Patent Profile

Which patents cover Baqsimi, 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	10,213,487		Y
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	10,765,602		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	6,938,798

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
Canada	3054484	DISPOSITIF DE DISTRIBUTION DE PRODUIT FLUIDE (DEVICE FOR DISPENSING A FLUID PRODUCT)
Australia	2019438995
Serbia	59918	NAZALNA PRAŠKASTA FORMULACIJA ZA TRETMAN HIPOGLIKEMIJE (NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA)

Supplementary Protection Certificates for BAQSIMI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2875043	C202430042	Spain		PRODUCT NAME: DASIGLUCAGON O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLES DEL MISMO, TAL COMO CLORHIDRATO DE DASIGLUCAGON; NATIONAL AUTHORISATION NUMBER: EU/1/24/1829; DATE OF AUTHORISATION: 20240724; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1829; DATE OF FIRST AUTHORISATION IN EEA: 20240724
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

Market Dynamics and Financial Trajectory for BAQSIMI

Last updated: December 26, 2025

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Executive Summary

BAQSIMI, a nasal powder formulation of the rescue drug glucagon, designated primarily for severe hypoglycemia management in diabetic patients, has experienced a notable market entry trajectory driven by evolving diabetes care paradigms and regulatory endorsements. Since its commercialization by Eli Lilly and Company in 2019, BAQSIMI has navigated competitive pressures, technological innovations, and shifting payer landscapes. This analysis dissects the market dynamics, assesses revenue forecasts, and identifies key growth drivers, challenges, and strategic opportunities shaping its financial trajectory.

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Introduction: Overview of BAQSIMI

Attribute	Details
Product	BAQSIMI (glucagon nasal powder)
Manufacturer	Eli Lilly and Company
Approval Date	May 2019 (FDA)
Indication	Treatment of severe hypoglycemia in diabetic patients, including children ages 2 and above
Administration	Intranasal powder, needle-free, convenient for emergency use

Key features:

• Non-injectable, needle-free administration increasing usability and adherence
• Rapid onset of action (~10 minutes)
• Suitable for caregivers and bystanders, broadening the therapeutic reach

1. Market Size and Segmentation

The global diabetes population represents a significant target market for BAQSIMI:

Market Segment	Estimated Numbers	Notes
Total Diabetes Population	~537 million (2021) [1]	Type 1 and Type 2 Diabetes combined
At Risk of Severe Hypoglycemia	~20-25%	Approximate, based on clinical data indicating prevalence in diabetes cohorts [2]
Pediatric Patients (≥2 years)	~20 million (global)	Specific age group indication

Estimated addressable market (2021):

• US adults with insulin-dependent diabetes (~23 million) [3]
• Pediatric (~1.8 million in US) [4]
• Total potential in US: ~25 million patients with a high risk for severe hypoglycemia

Market penetration considerations:

• Emergency preparedness measures
• Caregiver and patient education
• Prescription and distribution channels

2. Competitive Landscape

Competitors	Products	Market Share (Estimated)	Unique Selling Proposition (USP)
Lilly	BAQSIMI	~25-35% (initial launch phase)	Needle-free, nasal delivery, rapid action
Novo Nordisk	GlucaGen HypoKit (injectable)	Dominant (~60-70%)	Widely established, injectable route
Pfizer	Baqsimi (same as BAQSIMI), marketed in some regions	Converging with Lilly	Similar nasal formulation, regional distribution

Key observations:

• BAQSIMI's nasal route offers distinct convenience advantages.
• Injectable competitors still dominate due to established clinician familiarity.
• Patent protections and formulation patents bolster Lilly's market position.

3. Regulatory Policies and Reimbursement Environment

Policy Aspect	Implication	Sources
FDA Labeling	Supports pediatric use (≥2 years), broadening patient scope	[5]
Health Insurance Coverage	Increasing reimbursement for emergency medication kits	CMS, private payers
Prescribing Guidelines	Encourages non-injectable rescue devices	American Diabetes Association, 2020

Reimbursement:

• Medicaid and private insurers tend to reimburse for rescue medications, including nasal glucagon.
• Pricing strategies (around $250–$300 per device in the US) position BAQSIMI as a premium, but justified by ease of use and safety profile.

4. Market Adoption Drivers

• Ease of Administration: Needle-free nasal administration reduces training barriers for non-medical caregivers—crucial for pediatric use.
• Regulatory Endorsements: Formal FDA approval and pediatric labeling expand patient eligibility.
• Educational Campaigns: Structured programs enhance awareness among families managing insulin-dependent diabetes.
• Healthcare Provider Acceptance: Clinicians increasingly recommend nasal glucagon for social and safety reasons.

5. Challenges Limiting Growth

Challenge	Impact	Strategies to Mitigate
Competition from Injections	Resistance due to familiarity	Emphasize convenience and safety
Price Point	Barrier to access	Engage payers for favorable reimbursement
Limited Awareness	Underutilization	Expand educational outreach
Manufacturing Constraints	Supply chain stability	Scale-up production capabilities

6. Revenue Projections and Financial Trajectory

Year	Estimated Revenue (USD)	Notes
2019	~$20 million	Launch year, initial adoption
2020	~$50 million	Increased awareness, expanded distribution
2021	~$75 million	Market penetration accelerating
2022	~$150 million	Dominance in nasal rescue formulations
2023-2025	CAGR 25-30%	Growth driven by pediatric use, broader reimbursements, increased awareness

Assumptions underlying projections:

• Sustained growth in U.S. and expansion into European markets starting 2023
• Continuous educational programs reducing hesitation among caregivers
• Widening insurance coverage reducing out-of-pocket barriers

7. Strategic Opportunities

Opportunity	Rationale	Action Items
Geographic Expansion	European and Asian markets	Regulatory filings and clinical localizations
Product Line Extensions	Pediatric and elderly populations	Formulation improvements, device innovations
Partnerships	Health systems and emergency services	Co-marketing and distribution agreements
Digital Education	Mobile apps, training modules	Enhance caregiver and patient engagement

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Comparison with Competitors

Aspect	BAQSIMI	GlucaGen (injectable)	Other Nasal Glucagon (e.g., Xeris)
Route	Nasal powder	Injectable	Nasal powder
Ease of Use	High	Moderate	High
Approval	FDA 2019	FDA 2019	Pending/regulatory variations
Price (USD)	~$250–$300	~$180–$220 (injectable kit)	TBD
Pediatric Label	Yes	Yes	Pending

Conclusion: BAQSIMI’s distinct route and regulatory approvals position it favorably, yet pricing and clinical familiarity remain obstacles.

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Key Takeaways

• Market Entry & Growth: Since its 2019 approval, BAQSIMI has tapped into a sizable unmet need for easy-to-administer rescue hypoglycemia treatments, with revenues indicating strong initial growth.
• Growth Drivers: Adoption hinges on easing caregiver training, expanding pediatric use, and broadening insurance coverage.
• Challenges: Competition from injectables, regulatory hurdles in new markets, and payer access are significant hurdles.
• Financial Outlook: Forecasted to sustain high double-digit CAGR (25-30%) over 2023–2025, driven by geographical expansion and product line enhancements.
• Strategic Focus: Emphasize educational campaigns, leverage regulatory endorsements, and explore partnership opportunities to accelerate market penetration.

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FAQs

1. How does BAQSIMI compare to injectable glucagon in emergency scenarios?
BAQSIMI offers a needle-free, rapid, and easy-to-use alternative that reduces administration error and training barriers, especially appealing for lay caregivers and pediatric care.

2. What is the current global market share of BAQSIMI?
While exact figures are proprietary, estimates suggest BAQSIMI accounts for approximately 25-35% of the nasal rescue glucagon market in North America as of 2022, with potential for growth as awareness increases.

3. What regulatory hurdles remain for BAQSIMI's market expansion?
Approval processes in Europe and Asia require region-specific clinical data, and some markets have differing regulatory standards for emergency rescue medications, posing delays.

4. How significantly does pricing impact BAQSIMI’s adoption?
Price sensitivity is moderate; reimbursement policies and the high value placed on ease of use influence uptake more profoundly. Nonetheless, cost remains a consideration, particularly for uninsured or underinsured populations.

5. What are the future product development prospects for BAQSIMI?
Potential developments include formulations optimized for pediatric populations, longer shelf-life, and integrated digital support tools for educational purposes.

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References

1. International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
2. Cryer, P. E. (2017). Hypoglycemia in diabetes: pathophysiology, prevalence, and prevention. Endocrinology and Metabolism Clinics, 46(4), 743–757.
3. Centers for Disease Control and Prevention (CDC). (2022). National Diabetes Statistics Report.
4. American Diabetes Association. (2020). Standards of Medical Care in Diabetes—2020. Diabetes Care, 43(Supplement 1).
5. U.S. Food and Drug Administration. (2019). FDA approves new nasal medicine to treat severe hypoglycemia.

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This comprehensive overview provides business professionals with actionable insights into BAQSIMI's market dynamics and financial trajectory, underpinning strategic decision-making in the evolving diabetes therapeutics landscape.