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 nine 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-two 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:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	1,415
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 nine 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	8,021,344		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	BX	RX	Yes	No	8,226,610		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No	8,226,610		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No	8,231,573		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes	11,771,830		Y
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	BX	RX	Yes	No	8,206,360		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	9,149,579
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	9,056,170
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	8,926,594
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	7,918,823
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017	9,056,170
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017	9,149,579
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017	7,731,686

International Patents for AUVI-Q

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004325202	Devices, systems, and methods for medicament delivery
Australia	2006210865	Devices, systems, and methods for medicament delivery
Australia	2007245139	Devices, systems and methods for medicament delivery
Australia	2009200841	Devices, systems, and methods for medicament delivery
Australia	2009246525	Medicament delivery device having an electronic circuit system
Australia	2012201481	Devices, systems, and methods for medicament delivery
Australia	2015264857	MEDICAMENT DELIVERY DEVICE HAVING AN ELECTRONIC CIRCUIT SYSTEM

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

AUVI-Q (epinephrine) market dynamics and financial trajectory

Last updated: April 24, 2026

What is AUVI-Q and where does it sit in the epinephrine auto-injector market?

AUVI-Q is an epinephrine auto-injector indicated for emergency treatment of anaphylaxis. It competes in the branded auto-injector segment against other marketed epinephrine auto-injectors, primarily EpiPen (Mylan/Viatris; brand) and generic or authorized equivalents in various markets.

Core market structure

• Product category: Prescription epinephrine auto-injectors used for anaphylaxis.
• Commercial battleground: Price, payer contracting, rebates, patient out-of-pocket design, and channel access (retail pharmacy vs specialty/other distribution).
• Typical buying behavior: Payers manage spend through contracting and substitution; patients often face affordability constraints that affect adherence and refill behavior.

Commercial implication for AUVI-Q

• AUVI-Q’s market share and revenue growth track payer coverage outcomes and competitive pricing pressure from EpiPen and authorized/generic alternatives rather than demand expansion alone.

How has competitive pressure shaped AUVI-Q’s market share path?

AUVI-Q has operated under persistent competitive pressure in auto-injectors, where brand incumbents and price-to-coverage differentials drive formulary status.

Key competitive dynamics

• EpiPen’s incumbent position: EpiPen has long benefited from strong payer coverage and broad retail access, which tends to compress pricing and slow new entrants’ share gains unless payers offer favorable economics for a competitor.
• Coverage churn risk: Auto-injectors are high-cost items. Small changes in rebate structures can alter formulary positioning quickly.
• Substitution options: Where authorized equivalents and generics are available, formulary substitution increases.

What this means for AUVI-Q

• AUVI-Q’s revenue trajectory has been sensitive to whether payers treat it as a preferred alternative, and to the size and structure of rebates demanded to secure or maintain favorable placement.

What do the pricing and reimbursement mechanics imply for financial performance?

Auto-injectors are subject to tight reimbursement controls, with net revenue heavily influenced by rebate and discount policies rather than list price alone.

Net revenue drivers

• Government and commercial rebate pressure: Formulary access often requires rebates and discounts that reduce gross-to-net conversion.
• Patient affordability controls: Out-of-pocket caps and copay policies affect volume and refill rates, especially for privately insured and cash-pay switching.
• Contracting cadence: Annual or semiannual payer contracting cycles can cause step-changes in volume and net sales.

Financial trajectory implication

• Even if AUVI-Q maintains stable unit demand, net revenue growth is capped when competitors force payers to negotiate down prices or consolidate preference toward a single or dominant option.

Where do AUVI-Q revenues typically come from across channels and geographies?

AUVI-Q is primarily driven by:

• US retail pharmacy demand for emergency anaphylaxis treatment products.
• Commercial and managed care coverage that determines uptake.
• Limited international footprint relative to US scale in many branded drug categories.

Channel concentration effect

• For products of this type, revenue concentration in one or two large markets increases exposure to payer contracting outcomes and competitive activity.

What has the financial trajectory of AUVI-Q looked like in practice?

AUVI-Q’s financial trajectory has followed the pattern common to branded device-adjacent drugs facing intense competition: growth when coverage improves, then normalization when preferred status is challenged, offset by incremental demand from specific payer segments.

Observed inflection pattern in the class

• Revenue typically declines or flattens when:
  • competitors improve preferred positioning,
  • payer reimbursement reduces net pricing,
  • substitution increases.
• Revenue can stabilize when:
  • AUVI-Q is treated as an alternative with acceptable economics,
  • contracts limit direct substitution or require access for cost management.

Actionable read-through for investors and planners

• AUVI-Q’s medium-term performance is less about clinical differentiation and more about:
  • payer access continuity,
  • net price retention after rebate renegotiations,
  • competitive response timing.

How do manufacturing and distribution factors affect AUVI-Q’s revenue reliability?

Auto-injectors require consistent supply and distribution to maintain patient and payer confidence.

Revenue sensitivity points

• Supply continuity: Stockouts or allocation can convert formulary demand into lost sales because patients switch to in-stock alternatives.
• Distribution execution: Pharmacy channel fill rates determine persistence of usage.

Business consequence

• When supply is stable, AUVI-Q can capture and keep patient demand. When it is not, the product can lose momentum to preferred competitors even if it later restores supply.

What role do regulatory and product lifecycle events play in the financial outlook?

Lifecycle events for AUVI-Q can include:

• label expansions or changes in indication (direct demand impact),
• manufacturing and device updates (indirect demand impact via availability),
• patent and exclusivity status shifts (indirect demand impact through competitive entry).

Lifecycle-to-revenue mechanics

• Exclusivity/patent pressure: accelerates entry of competitors or authorized equivalents.
• Regulatory changes: can shift payer and provider behavior, altering demand mix.

How does patent and exclusivity posture shape the competitive timeline and financial runway?

AUVI-Q’s market outlook is shaped by the timetable of:

• the expiry of key patents or exclusivity protections,
• the timing of generic or authorized competitive products.

Financial planning implications

• A credible “runway” for AUVI-Q depends on:
  • what is still protected,
  • whether competitors can enter without infringing,
  • whether payers will move to substitutes when protection ends.

What market dynamics should drive scenario planning for AUVI-Q revenues?

Scenario drivers in the epinephrine auto-injector category generally include:

Payer contracting and preferred status

• preferred versus non-preferred positioning changes net price and volume.

Competitor pricing and access

• dominant brand rebates and patient program structures affect switching incentives.

Substitution intensity

• authorized/generic availability changes the elasticity of demand by formulary.

Policy and reimbursement environment

• government reimbursement and commercial PBM strategies can accelerate shifts in channel share.

Financial trajectory summary: what the dynamics imply for AUVI-Q

AUVI-Q’s financial trajectory in the epinephrine auto-injector market is governed by coverage and economics, not only by total anaphylaxis incidence. In a category where competitors can lock in payer preference through contracting leverage, AUVI-Q’s revenue path typically exhibits:

• step-changes around payer contract renewals,
• plateau or decline when preferred positioning shifts away,
• fragile stability tied to rebate and supply continuity.

Key Takeaways

1. AUVI-Q competes in a payer-driven market where revenue is dominated by net pricing outcomes, not list price.
2. Competitive pressure from incumbent and substitute auto-injectors drives formulary churn, limiting sustained unit and net growth.
3. AUVI-Q’s financial trajectory is most sensitive to payer contracting, rebate structures, and substitution intensity at retail pharmacy.
4. Reliability of supply and distribution affects persistence of demand in competitive channels.
5. Patent and exclusivity milestones define the competitive timeline and shape the product’s revenue runway.

FAQs

1) What primarily determines AUVI-Q revenue in the US market?
Net pricing tied to payer contracts, rebates, and preferred formulary status, plus retail channel execution and substitution behavior.

2) Does AUVI-Q’s clinical value translate directly into revenue growth?
Not automatically. In this category, payer coverage and contracting economics determine whether clinical differentiation converts into sustained unit share.

3) Why do epinephrine auto-injector revenues move in step-changes?
Because payer contracting cycles and rebate renegotiations can rapidly change net price and formulary positioning.

4) How does competition affect AUVI-Q’s financial runway?
Competition accelerates substitution risk and compresses net pricing, reducing growth or triggering declines once payer preference shifts.

5) What operational factor matters most for maintaining AUVI-Q sales?
Supply continuity and pharmacy channel fill rates; stockouts can permanently shift demand to alternatives.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). AUVI-Q (epinephrine) prescribing information. FDA. https://www.accessdata.fda.gov/
[2] U.S. Securities and Exchange Commission. (n.d.). Filings referencing AUVI-Q financial performance and market conditions. SEC EDGAR. https://www.sec.gov/edgar/search/
[3] IQVIA. (n.d.). U.S. immunology and allergy auto-injector market analytics (category-level coverage and share reports). IQVIA. https://www.iqvia.com/