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

2031

2032

2033

2034

2035

2036

2037

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Auvi-Q (2023)

Total Spending

$719K

Total Claims

958

Beneficiaries

782

Avg Cost/Unit

$315.26

Spending Trend

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

YoY Change:+6.4%

5yr CAGR:-40.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs2 inactive

10 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

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