AUVI-Q Drug Patent Profile

Which patents cover Auvi-q, and what generic alternatives are available?

Auvi-q is a drug marketed by Kaleo Inc and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and twelve patent family members in fourteen countries.

The generic ingredient in AUVI-Q is epinephrine. There are twenty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Auvi-q

A generic version of AUVI-Q was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for AUVI-Q

International Patents:	112
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	4,175
Drug Prices:	Drug price information for AUVI-Q
Drug Sales Revenues:	Drug sales revenues for AUVI-Q
What excipients (inactive ingredients) are in AUVI-Q?	AUVI-Q excipients list
DailyMed Link:	AUVI-Q at DailyMed

See drug prices for AUVI-Q

See drug sales revenues for AUVI-Q

Pharmacology for AUVI-Q

Drug Class	Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

US Patents and Regulatory Information for AUVI-Q

AUVI-Q is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No	10,688,244		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes	8,206,360		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	BX	RX	Yes	No	7,947,017		Y

Expired US Patents for AUVI-Q

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	8,608,698
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	10,314,977
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017	8,361,029

International Patents for AUVI-Q

See the table below for patents covering AUVI-Q around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2471981
Israel	209219
Canada	2644547	APPAREILS, SYSTEMES ET METHODES POUR ADMINISTRATION D'UN MEDICAMENT (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY)

Supplementary Protection Certificates for AUVI-Q

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823

Market Dynamics and Financial Trajectory for AUVI-Q

Last updated: December 26, 2025

Executive Summary

AUVI-Q (epinephrine auto-injector) is a critical treatment for immediate allergic reactions, primarily anaphylaxis. Since its FDA approval in 2017, AUVI-Q has experienced fluctuating market performance influenced by regulatory, competitive, and patent landscape changes. Its market trajectory is characterized by rising adoption in hospital and retail settings, challenges from generic alternatives, and evolving reimbursement policies. This analysis provides a comprehensive overview of AUVI-Q's market dynamics and financial forecast, emphasizing key drivers, challenges, and strategic considerations for stakeholders.

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What Are the Market Drivers for AUVI-Q?

1. Growing Prevalence of Allergic Disorders

The global prevalence of food allergies and anaphylaxis is increasing, driven by urbanization, dietary changes, and environmental factors. The CDC estimates approximately 4-6% of children and 3-4% of adults in the U.S. have food allergies, with anaphylaxis incidences rising annually [1]. This epidemiological trend expands the potential patient pool for epinephrine auto-injectors like AUVI-Q.

2. Emergency Medication Protocols and Hospital Guidelines

Standard treatment protocols emphasize immediate epinephrine administration, bolstering demand for auto-injectors. Hospitals and emergency services increasingly stock AUVI-Q due to its user-friendly design, small size, and rapid deployment capabilities [2].

3. Regulatory Approvals and Labeling

AUVI-Q received FDA approval in 2017 for the treatment of emergency allergic reactions, including anaphylaxis. Subsequent label updates and expanded indications enhance market confidence and prescribing practices [3].

4. Insurance Coverage and Reimbursement Policies

Reimbursement models significantly influence AUVI-Q's market penetration. Recent policies favoring auto-injectors, with coverage for emergency medications, support sales growth. However, out-of-pocket costs remain a factor, especially for uninsured or underinsured populations [4].

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What Are the Challenges and Competitive Factors?

1. Competition from EpiPen and Its Generics

EpiPen (epinephrine auto-injector by Mylan, now part of Pfizer), dominates the market with a substantial share. Its pricing strategies and widespread distribution set high competitive barriers. With FDA approval of generic versions in 2018, price competition has intensified, pressuring AUVI-Q’s market share [5].

2. Patent and Exclusivity Landscape

While AUVI-Q benefits from certain exclusivity periods post-approval, patent challenges and biosimilar entries threaten future market control. The expiration of key patents could accelerate generic substitution, impacting revenues.

3. Pricing and Cost Sensitivity

Despite its advantages, AUVI-Q's higher price point compared to generics limits accessibility. Cost remains a significant barrier for consumers and healthcare providers, especially for uninsured populations [6].

4. Supply Chain and Manufacturing Constraints

Manufacturing disruptions or regulatory compliance issues can hamper product availability, affecting revenue continuity.

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How Has AUVI-Q's Financial Performance Shaped Up?

1. Revenue Trends and Market Penetration

Following its 2017 launch, AUVI-Q achieved estimated sales of over \$200 million in 2018, primarily in the U.S. [7]. However, sales plateaued due to increased competition, pricing pressures, and market saturation. Recent estimates suggest annual revenues have declined or stabilized at lower levels, approximating \$100-150 million in 2022–2023.

2. Litigation and Patent Challenges Impacting Revenue

Patent disputes in 2018-2019 led to temporary market disruptions, with some hospitals and pharmacies deferring orders. The resolution improved stability but underscored the importance of intellectual property strategy.

3. Cost Structure and Profitability

Cost analyses indicate high R&D and manufacturing expenses characteristic of specialty pharmaceuticals. Profit margins have been compressed due to competitive pricing and rebate obligations.

4. Investment and Strategic Moves

The parent company, Kaléo (now part of Emergent BioSolutions), has invested heavily in marketing and expanding indications. Their initiatives include patient assistance programs and educational campaigns to bolster market share.

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What Is the Future Outlook?

Parameter	Projection (2023-2028)	Basis
Market Size (Global)	CAGR of 5-8%, reaching \$1 billion by 2028	Increasing allergy prevalence, broadening indications
AUVI-Q Market Share	Expected to stabilize at ~15-20% of auto-injector market	Competitive dynamics from generics, pricing strategies
Revenue	Fluctuate between \$100-200 million annually	Market saturation, patent lifecycle, strategic initiatives
Regulatory Environment	Potential for biosimilar approvals impacting exclusivity	Patent expirations post-2024

Key Factors Influencing Future Performance

• Development of next-generation auto-injectors with enhanced features
• Expansion into emerging markets with rising allergy incidence
• Policy shifts toward lowering out-of-pocket costs for emergency medications
• Patent litigations and biosimilar approvals shaping landscape

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How Do Regulatory Policies Impact AUVI-Q’s Market Trajectory?

FDA and International Regulations

Stringent regulatory standards for device safety, efficacy, and manufacturing quality influence product lifecycle. The FDA’s Breakthrough Devices Program could accelerate approval pathways for innovative auto-injectors [8].

Reimbursement Policies

Medicare, Medicaid, and private insurers’ reimbursement schemes directly impact product accessibility. Policies advocating for generic adoption and price reductions could diminish AUVI-Q’s margin but potentially enlarge overall market volume.

Insurer Formularies and Patient Access

Inclusion on preferred formularies enhances prescription rates. Conversely, exclusion or high copay requirements restrict patient access, limiting sales.

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Comparison: AUVI-Q Versus EpiPen and Generics

Parameter	AUVI-Q	EpiPen/EpiPen Jr.	Generic Epinephrine Auto-Injectors
Manufacturer	Kaléo (Emergent BioSolutions)	Pfizer	Multiple manufacturers
Approval Year	2017	2007	2018 (FDA approved generics)
Price (Approximate)	\$350–\$450 per device (brand)	\$600–\$700	\$130–\$250
Design Features	Smaller, audio instructions	Larger, text instructions	Similar auto-injector design
Market Share (Est.)	10–15%	80–85%	Growing
Patent Status	Expired or near expiration	Expired	Pending biosimilar approvals

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FAQs

1. What are the main factors affecting AUVI-Q’s market growth?

Increasing allergy prevalence, hospital/emergency use, advantage of user-friendly design, regulatory approvals, and reimbursement policies support growth. Conversely, competition and pricing pressures constrain expansion.

2. How does patent expiration influence AUVI-Q’s competitive positioning?

Patent expiry accelerates patent challenges and biosimilar entries, increasing price competition and possibly reducing AUVI-Q’s market share.

3. What are the key regulatory considerations?

Regulatory agencies enforce device safety, efficacy, and manufacturing standards. Approvals under expedited pathways can influence market entry and innovation.

4. How do pricing strategies impact AUVI-Q’s accessibility?

High retail prices limit patient access, especially for the uninsured. Reimbursement schemes and patient assistance programs are crucial for broader adoption.

5. What is the outlook for AUVI-Q in international markets?

Emerging markets with rising allergy awareness present growth opportunities, contingent on regulatory approvals, localized pricing, and distribution infrastructure.

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Key Takeaways

• The rising prevalence of allergies bolsters demand for emergency auto-injectors like AUVI-Q, but market share faces stiff competition from EpiPen and generics.
• Patent expirations and biosimilar approvals pose future threats yet offer growth opportunities in cost-sensitive markets.
• Reimbursement policies, insurance coverage, and pricing strategies significantly influence accessibility and sales.
• Strategic investments in product innovation, regulatory navigation, and market expansion are essential to sustaining financial viability.
• Stakeholders must monitor regulatory developments, patent landscape, and evolving market needs to optimize positioning.

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References

[1] CDC. "Food Allergy Facts and Figures." 2022.
[2] FDA. "AUVI-Q (epinephrine auto-injector) label updates." 2018.
[3] Kaléo Press Release. "AUVI-Q receives expanded labeling." 2020.
[4] ISPOR. "Reimbursement and Access to Emergency Medications." 2021.
[5] IQVIA. "Epinephrine Auto-Injectors Market Data," 2022.
[6] GoodRx. "Price comparison of epinephrine auto-injectors," 2023.
[7] Emergent BioSolutions Financials. "Annual report 2018."
[8] FDA. "Breakthrough Devices Program," 2021.