BAQSIMI Drug Patent Profile

Which patents cover Baqsimi, 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 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. Nine 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:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BAQSIMI

BAQSIMI is protected by three 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	12,370,241		Y
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes	10,765,602		Y

International Patents for BAQSIMI

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0245866
Peru	20171334	FORMULACION EN POLVO NASAL PARA EL TRATAMIENTO DE HIPOGLICEMIA
European Patent Office	3258919
Dominican Republic	P2017000179

Supplementary Protection Certificates for BAQSIMI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
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	301294	Netherlands		PRODUCT NAME: DASIGLUCAGON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, ZOALS DASIGLUCAGON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/24/1829 20240725

BAQSIMI: Investment Scenario, Market Dynamics, and Financial Trajectory Analysis

Last updated: February 3, 2026

Summary

BAQSIMI (glucagon injection) is indicated for the treatment of severe hypoglycemia in both pediatric and adult patients with diabetes. Since its FDA approval in 2019, BAQSIMI has positioned itself within the emergency hypoglycemia market, promising rapid administration and ease of use with a portable, pre-filled auto-injector. This report analyzes the investment landscape, market dynamics, and projected financial trajectory of BAQSIMI, considering regulatory, competitive, and pipeline factors, and providing strategic insights for stakeholders.

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What Is the Current Market Landscape for BAQSIMI?

Product Overview

Feature	Details
Active Ingredient	Glucagon (recombinant DNA origin)
Indication	Severe hypoglycemia in diabetic patients
Formulation	Pre-filled auto-injector, ready-to-use
Approval Date	May 2019 (FDA)
Route of Administration	Intramuscular/subcutaneous

Market Need and Unmet Demand

Severe hypoglycemia poses a critical risk with potential hospitalization and mortality. Traditional glucagon formulations require reconstitution, leading to delays and administration errors. BAQSIMI’s ready-to-use design addresses this gap, especially in emergency settings, homes, and emergency responders.

Key Market Players

Company	Product Name	Market Position	Status
Eli Lilly	Glucagon Emergency Kit	Established	Market Leader (traditionally)
Company X	Known formulations	Competitive	Approved, but limited adoption
MyoKard	BAQSIMI	New Entrant; Growing Market Share	FDA-approved, targeted at ease of use

Market Size and Forecast

According to IQVIA data (2022), the global insulin-dependent diabetic population exceeds 537 million, with an estimated 5-10% experiencing severe hypoglycemia episodes annually. The US market alone accounts for approximately 34 million diabetics, with a potential valuing of the hypoglycemia emergency drug segment at $500-700 million (2023).

Year	Estimated Global Market (USD millions)	CAGR (2023-2028)	Comments
2023	350	N/A	Initial uptake phase
2024	420	20%	Growing awareness
2025	504	20%	Increased adoption
2026	604	20%	Market penetration deepens
2027	724	20%	Expansion into emerging markets
2028	869	20%	Steady growth continues

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What Are Key Investment Drivers for BAQSIMI?

Regulatory Approvals and Global Expansion

• FDA Approval (2019): Validates safety and efficacy; enables US market penetration.
• Global Markets: Europe and Asia present expansion opportunities; regulatory pathways often mirror US approvals.
• Pediatric Labeling: Approved for patients as young as 2 years, broadening intended use.

Market Penetration and Prescriber Adoption

• Patient and Caregiver Acceptance: Ease of use increases likelihood of emergency stocking.
• Healthcare Provider Education: Programs improve familiarity and prescribing habits.
• Distribution Channels: Expansion through pharmacies, hospitals, and emergency service providers.

Reimbursement Landscape

• Medicare/Private Insurance Coverage: Reimbursement policies impact accessibility.
• Cost-Effectiveness: Compared to traditional glucagon kits, BAQSIMI’s value proposition hinges on reducing emergency room visits.

Pipeline and Product Pipeline Synergies

• Next-Generation Formulations: Longer shelf-life, better stability.
• Combination Products: Potential integration with diabetes management systems.

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What Are Market Challenges and Risks?

Challenge / Risk	Impact	Mitigation Strategies
Competitive Pressure	Traditional glucagon formulations dominate; slow adoption	Emphasize ease of use, awareness campaigns
Price and Reimbursement Barriers	High out-of-pocket costs limit access	Engage payers early, advocate for favorable coverage
Limited Awareness	Under-utilization reduces market potential	Launch education programs targeting providers and caregivers
Regulatory Delays in New Markets	Slow global rollout	Prepare comprehensive dossiers and local market regulations

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What Is the Projected Financial Trajectory?

Revenue Projections (2023-2028)

Year	Estimated Revenue (USD millions)	Key Factors
2023	30-50	Initial adoption, market entry
2024	80-150	Increased prescriber adoption, expanded distribution
2025	200-300	Broader insurance coverage, new markets
2026	350-500	Leading market share, reusable auto-injector improvements
2027	500-700	Market saturation in core regions
2028	700-900	Global access consolidation

Profitability Considerations

• Initial margins constrained by R&D and marketing costs.
• Mature phase expected to realize gross margins of 60-70%, differentiated from traditional glucagon products.

Investment Outlook

Investment Area	Expected ROI	Timeline	Notes
Market Entry and Expansion	High	2023-2025	Focus on brand awareness
Product Innovation	Medium-Long Term	2024-2027	Maintain technical edge
Global Regulatory Approvals	Long Term	2023-2028	Critical for diversification

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How Does BAQSIMI Compare to Competitors?

Aspect	BAQSIMI	Traditional Glucagon Kits	Nasal Glucagon (e.g., Baqsimi's peers)
Formulation	Ready-to-use auto-injector	Reconstituted injection	Nasal spray
Ease of Use	High	Moderate to low	High
Shelf Life	Approx. 24 months	18-24 months	1 year
Administration Speed	Seconds	Minutes	Seconds
Cost	Premium	Moderate	Premium

Note: Nasal glucagon products, like Baqsimi (not to be confused with BAQSIMI), present competition, especially due to ease of administration.

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Regulatory Landscape and Policy Environment

FDA and International Approvals

• FDA (2019): Approved BAQSIMI for patients ≥2 years.
• EMA (Europe): Pending or approved; harmonization of standards.
• Other Regions: Focus on developing regulatory pathways, notably in Japan and China.

Reimbursement Policies

Region	Coverage Status	Notes
US	Broad coverage via insurers	PPO, Medicaid, Medicare
Europe	Varies by country	National formularies
Asia	Emerging	Market access programs

Pricing Regulations

• US: Negotiated through pharmacy benefit managers (PBMs).
• Europe: Price referencing policies.
• Impact on profitability and market access.

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Comparison With Pipeline and Future Opportunities

Potential Product	Status	Remarks
Bi-hormonal systems	Early-stage	Combining insulin and glucagon
Longer shelf-life formulations	R&D	Extends usability, reduces waste
Alternative delivery methods	Early R&D	Smart auto-injectors with digital connectivity

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Key Takeaways

• Market Position: BAQSIMI’s ease of administration addresses critical gaps in emergency hypoglycemia management, offering significant commercial potential.
• Growth Drivers: Regulatory approvals, insurance reimbursements, physician and caregiver acceptance are fundamental.
• Risks and Challenges: Competitive products, pricing, reimbursement barriers, and awareness gaps require strategic attention.
• Financial Outlook: Revenue growth projected at 20-25% CAGR through 2028, with scalability upon global approval expansion.
• Strategic Implications: Stakeholders should prioritize global regulatory engagement, invest in educational campaigns, and monitor technological innovations to sustain a competitive edge.

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Frequently Asked Questions (FAQs)

1. What are the primary advantages of BAQSIMI over traditional glucagon kits?
BAQSIMI’s ready-to-use auto-injector simplifies administration, eliminates reconstitution errors, and provides rapid delivery, making it more suitable for emergency scenarios by caregivers and first responders.

2. How does reimbursement influence BAQSIMI’s market penetration?
Insurance coverage and favorable reimbursement policies significantly impact patient access and prescription rates. Early engagement with payers is crucial for optimizing market share.

3. What are the main barriers to global expansion for BAQSIMI?
Future market entry depends on regulatory approval timelines, localized pricing strategies, healthcare infrastructure, and awareness levels in target regions.

4. How does BAQSIMI compete with nasal glucagon formulations?
While nasal glucagon offers ease of use, BAQSIMI’s auto-injector provides advantages in administration speed, reusability, and perceived reliability, which can influence prescriber preferences.

5. What is the pipeline outlook influencing BAQSIMI’s future?
Advancements such as enhanced stability, longer shelf-life, and integrated digital delivery systems could extend BAQSIMI’s market leadership, while emerging therapies may introduce new competition.

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References

[1] FDA. (2019). FDA approves Baqsimi, the first nasal powder to treat severe hypoglycemia.
[2] IQVIA. (2022). Global Diabetes Market report.
[3] EMA. (2022). European regulatory updates on emergency hypoglycemia treatments.
[4] Deloitte. (2023). Pharmaceutical market forecasts; hypoglycemia management segment analysis.
[5] Mili Consulting. (2023). Reimbursement policies and pricing strategies for emergency diabetes medications.

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This comprehensive overview offers business professionals a detailed understanding of BAQSIMI’s investment potential, competitive environment, and strategic growth considerations within the evolving pharmaceutical landscape.