AUVI-Q Drug Patent Profile

When do Auvi-q patents expire, and when can generic versions of Auvi-q launch?

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. Twenty-six 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:	88
Patent Applications:	1,800
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	201739-001	Aug 10, 2012	BX	RX	Yes	No			Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes			Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes			Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No			Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No			Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No			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	201739-002	Aug 10, 2012
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012

International Patents for AUVI-Q

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012201481	Devices, systems, and methods for medicament delivery
China	101111281	Devices, systems, and methods for medicament delivery
Japan	5277157
United Kingdom	2449027	Devices, systems and methods for medicament delivery
United Kingdom	2434548	Devices, systems, and methods for medicament delivery
United Kingdom	2480407	Autoinjector with locking mechanism at the injection end

Market Dynamics and Financial Trajectory for Auvi-Q

Introduction

Auvi-Q, an epinephrine auto-injector developed by Kaleo, Inc., has been a significant player in the anaphylaxis treatment market, though its journey has been marked by both successes and challenges. Here, we delve into the market dynamics and financial trajectory of Auvi-Q, highlighting its key milestones, competitive landscape, and financial performance.

Market Landscape

The epinephrine auto-injector market is dominated by a few key players, with Mylan's EpiPen being the most prominent. However, Auvi-Q has carved out a niche for itself with its unique features, such as automated voice instructions to guide users through the injection process[4].

Competitive Advantage

Auvi-Q's innovative design and user-friendly interface have garnered positive feedback from allergists and patients. The device's ability to provide clear, audible instructions makes it particularly appealing, especially for those who may be anxious or unfamiliar with the injection process[4].

Challenges and Setbacks

One of the most significant setbacks for Auvi-Q was the recall initiated by Sanofi in 2015 due to concerns over inaccurate dosing. This recall led to a temporary withdrawal from the market, giving Mylan's EpiPen a near-monopoly in the epinephrine injection field[4].

Re-entry and Partnerships

Partnership with Walgreens

After addressing the issues that led to the recall, Kaleo re-entered the market and formed a strategic partnership with Walgreens. This partnership was crucial as it helped ensure wider availability of Auvi-Q across the United States. Walgreens' commitment to working with Kaleo to meet the demand for epinephrine auto-injectors was a significant boost for Auvi-Q's market presence[1].

Market Traction

The partnership with Walgreens marked a turning point for Auvi-Q, indicating that the product was gaining traction in the market. This was particularly evident as Mylan faced production issues with EpiPen, creating an opportunity for Auvi-Q to fill the supply gap[1].

Financial Performance

Pricing and Accessibility

Despite a higher list price of $4,900 compared to Mylan's generic EpiPen at $300, Kaleo has implemented programs to make Auvi-Q more accessible. Many patients can obtain Auvi-Q free of charge or for a reduced cash price of $360, which has helped in increasing its adoption[1].

Cost of Care

Studies have shown that patients prescribed Auvi-Q have lower healthcare resource use and costs associated with anaphylaxis treatment compared to those using other epinephrine auto-injectors. This includes lower costs for outpatient visits, hospitalizations, and emergency care, making Auvi-Q a cost-effective option in the long run[3].

Healthcare Costs Analysis

Total Cost of Care

A U.S. commercial claims analysis revealed that patients prescribed Auvi-Q had significantly lower total costs of care excluding prescription costs. The mean total cost of care for Auvi-Q patients was $1,155 compared to $1,582 for those using other EAIs, with significant savings observed in inpatient costs[3].

Outpatient and Inpatient Costs

The study also highlighted that Auvi-Q patients had fewer hospitalizations and lower costs associated with outpatient visits and emergency care. These findings suggest that Auvi-Q not only provides effective treatment but also reduces the overall healthcare expenditure for anaphylaxis patients[3].

Financial Health of Kaleo

While specific financial details of Kaleo are not extensively available, the company's strategic moves and partnerships indicate a stable financial footing. The ability to negotiate favorable pricing and accessibility programs suggests a robust financial strategy.

Market Growth and Projections

Market Size and Growth

The epinephrine pen market is valued at approximately $1.3 billion, with substantial growth predicted over the next several years. As Auvi-Q regains market share, it is poised to benefit from this growing demand[4].

Competitive Positioning

Despite Mylan's dominant position, Auvi-Q's unique features and cost-effectiveness position it as a viable alternative. The recall of Teva's generic EpiPen until the second half of the next year further solidifies Auvi-Q's competitive stance[4].

Key Takeaways

• Innovative Design: Auvi-Q's automated voice instructions set it apart in the market.
• Partnerships: The partnership with Walgreens has been crucial for increasing Auvi-Q's market presence.
• Cost-Effectiveness: Studies show that Auvi-Q reduces healthcare costs associated with anaphylaxis treatment.
• Market Growth: The epinephrine pen market is growing, and Auvi-Q is well-positioned to capture a significant share.
• Competitive Landscape: Despite Mylan's dominance, Auvi-Q offers a compelling alternative.

FAQs

What is Auvi-Q?

Auvi-Q is an epinephrine auto-injector designed for the treatment of anaphylaxis, featuring automated voice instructions to guide users through the injection process.

Why was Auvi-Q recalled in 2015?

Auvi-Q was recalled in 2015 due to concerns over inaccurate dosing, which led to its temporary withdrawal from the market.

How does Auvi-Q compare to EpiPen in terms of cost?

While Auvi-Q has a higher list price than EpiPen, many patients can obtain it free of charge or for a reduced cash price of $360, making it more accessible.

What are the healthcare cost benefits of using Auvi-Q?

Studies have shown that patients prescribed Auvi-Q have lower healthcare costs associated with anaphylaxis treatment, including lower costs for outpatient visits, hospitalizations, and emergency care.

What is the current market position of Auvi-Q?

Auvi-Q has regained market traction through its partnership with Walgreens and by offering a cost-effective alternative to EpiPen, positioning it well in the growing epinephrine pen market.

Sources

1. Biopharma Dive: "As EpiPen struggles, Walgreens, Kaleo ink Auvi-Q partnership"
2. Simply Wall St: "Applied UV (AUVI.Q) Balance Sheet & Financial Health Metrics"
3. Auvi-Q: "Healthcare resource use and costs of care study"
4. Fierce Pharma: "Sanofi's Auvi-Q recall puts Mylan's rival EpiPen in full control of blockbuster market"
5. Aquestive Therapeutics: "Full Year 2023 Financial Results and Business Update"