Viewing data from:

AUVI-Q

NDA

EPINEPHRINE | N201739 | KALEO INC

3 strengths9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Expiring < 1yr (2)Active (7)Today

2026

2027

2028

2029

2030

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2033

2034

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2038

Today

Mar. 12, 2028

Nov. 2, 2029

Feb. 27, 2027

Apr. 10, 2029

Nov. 25, 2028

Dec. 21, 2037

Dec. 21, 2037

Dec. 12, 2026

Dec. 21, 2037

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

272 trials from ClinicalTrials.gov — 4 recruiting, 2 active, 191 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Functional Endoscopic Sinus Surgery Study NCT03970655	Phase 1/2	Active	University of Florida	80	2019-09-25 → 2027-01-23
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia NCT01059786	Phase 2	Active	National Cancer Institute (NCI)	69	2010-07-01 → 2027-12-31
Exparel Injection Effect on Postoperative Opioid Usage NCT04085913	Early Phase 1	By Invitation	University of Missouri-Columbia	100	2019-09-30 → 2025-07
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine NCT03906617	Phase 4	Recruiting	The Cooper Health System	34	2019-04-10 → 2022-06-10
Vasoactive Drugs in Intensive Care Unit NCT02118467	Phase 4	Recruiting	University of Chicago	836	2014-05-15 → 2026-12-01
Epinephrine Dose: Optimal Versus Standard Evaluation Trial NCT03826524	Phase 4	Recruiting	Unity Health Toronto	3,790	2023-05-24 → 2028-12
A Novel Method for Chronic Anal Fissure Treatment NCT02628522	N/A	Completed	Clinical Centre of Serbia	6	2014-12 → 2015-10
Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)NCT02478398	Phase 3	Completed	Merck Sharp & Dohme LLC	1,025	2015-07-20 → 2018-11-19
Effectiveness Study of Different Local Anesthetic Mixtures NCT01243112	Phase 4	Completed	Scott and White Hospital & Clinic	25	2010-05 → 2010-09
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients NCT01357642	Phase 3	Completed	Amphastar Pharmaceuticals, Inc.	373	2011-07 → 2011-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$309.85

per ea

Lowest NADAC/Unit

$309.38

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60842002202AUVI-Q 0.15 MG AUTO-INJECTOR	$309.85	EA	Brand	—	2026-07-01
60842002102AUVI-Q 0.1 MG AUTO-INJECTOR	$309.55	EA	Brand	—	2026-07-01
60842002302AUVI-Q 0.3 MG AUTO-INJECTOR	$309.38	EA	Brand	—	2026-07-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$303.11

Highest Price

$568.79

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60842-0021-02AUVI-Q 0.1MG/0.1ML INJECTOR	$568.79	FSS	Kaleo, Inc.	05/14/2028
60842-0021-02AUVI-Q 0.1MG/0.1ML INJECTOR	$359.23	Big4	Kaleo, Inc.	05/14/2028
60842-0022-02AUVI-Q 0.15MG/0.15ML INJECTOR	$568.79	FSS	Kaleo, Inc.	05/14/2028
60842-0022-02AUVI-Q 0.15MG/0.15ML INJECTOR	$303.11	Big4	Kaleo, Inc.	05/14/2028
60842-0023-02AUVI-Q 0.3MG/0.3ML INJECTOR	$568.79	FSS	Kaleo, Inc.	05/14/2028
60842-0023-02AUVI-Q 0.3MG/0.3ML INJECTOR	$350.54	Big4	Kaleo, Inc.	05/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Auvi-Q (2024)

Total Spending

$713K

Total Claims

1,035

Beneficiaries

876

Avg Cost/Unit

$300.57

Spending Trend

$4.1M(2019)→$3.0M(2020)→$3.1M(2021)→$362K(2022)→$719K(2023)→$713K(2024)

YoY Change:-4.7%

5yr CAGR:-40.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs2 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

WOCKHARDT LTDEPINEPHRINE USP

DMF 212132007

CAMBREX PROFARMACO MILANO SRLEPINEPHRINE

DMF 259892012

SUN PHARMACEUTICAL INDUSTRIES LTDEPINEPHRINE USP

DMF 286172014

MATRIX PHARMACORP PRIVATE LTDEPINEPHRINE USP

DMF 287492014

CURIA NEW YORK INCEPINEPHRINE, USP

DMF 292102015

TRANSO PHARM HANDELS GMBHEPINEPHRINE TARTRATE/ADRENALINE TARTRATE

DMF 309962016

AMPHASTAR NANJING PHARMACEUTICALS INCEPINEPHRINE USP

DMF 330362018

GLAND PHARMA LTDEPINEPHRINE

DMF 353842020

PHLOW CORPEPINEPHRINE USP

DMF 375812024

GLAND PHARMA LTDEPINEPHRINE (LOW EPIMER)

DMF 387332023

OLON SPAEPINEPHRINE

DMF 407962024

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDEPINEPHRINE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 431562025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveEPINEPHRINE HYDROGENTARTRATE

DMF 57791984

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveEPINEPHRINE

DMF 58221985

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
May 5, 2025	SUPPL -30	View Letter (PDF)
Feb 29, 2024	SUPPL -28	View Letter (PDF)
Oct 1, 2019	SUPPL -15	View Letter (PDF)
Nov 17, 2017	SUPPL -9	View Letter (PDF)
Nov 17, 2017	SUPPL -8	View Letter (PDF)
Feb 23, 2017	SUPPL -6	View Letter (PDF)
May 19, 2016	SUPPL -4	View Letter (PDF)
Aug 14, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.3MG/DELIVERY

RLDBX

6 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Aug 10, 2012

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7947017	Mar 12, 2028	—	—	Yes	—	—
8021344	Nov 2, 2029	—	—	Yes	—	—
8206360	Feb 27, 2027	—	—	Yes	—	—
8226610	Apr 10, 2029	—	—	Yes	—	—
8231573	Nov 25, 2028	—	—	Yes	—	—
11590286	Dec 12, 2026	—	—	Yes	—	—

#002 — EQ 0.15MG/DELIVERY

RLDBX

9 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Aug 10, 2012

#003 — EQ 0.1MG/DELIVERY

RLD

9 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Nov 17, 2017