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NEFFY

NDA

EPINEPHRINE | N214697 | ARS PHARMACEUTICALS OPERATIONS INC

2 strengths8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)TodayIPRPTAB Challenge

2026

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Today

Feb. 6, 2038

Feb. 6, 2039IPR

Feb. 6, 2038

Feb. 6, 2039

Feb. 6, 2039

Feb. 6, 2039

Feb. 6, 2039

Feb. 6, 2039

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2021-01324	10682414	IPR	Amphastar Pharmaceuticals, Inc.	Final Written Decision	2021-08-12	2025-03-07

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
ARS PHARMACEUTICALS OPERATIONS, INC. et al v. LUPIN INC. et al 2:2026cv02036 8 patentsANDA 221269epinephrine	D.N.J.	2026-02-26	Terminated 2026-04-27	—
ARS PHARMACEUTICALS OPERATIONS, INC. et al v. LUPIN INC. et al 2:2025cv15123 8 patentsANDA 220047epinephrine nasal spray	D.N.J.	2025-08-29	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

5 letters from Drugs@FDA

Date	Submission	Document
Mar 30, 2026	SUPPL -4	View Letter (PDF)
Feb 27, 2026	SUPPL -2	View Letter (PDF)
Oct 28, 2025	SUPPL -3	View Letter (PDF)
Mar 6, 2025	SUPPL -1	View Letter (PDF)
Aug 12, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2MG/SPRAY

RLD

8 patents0 exclusivities▴

SPRAY;NASAL | Approved: Aug 9, 2024

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10576156	Feb 6, 2038	—	—	Yes	—	—
10682414	Feb 6, 2039	—	—	—		—
11173209	Feb 6, 2038	—	—	—		—
11191838	Feb 6, 2039	—	—	Yes		—
11717571	Feb 6, 2039	—	—	—		—
11744895	Feb 6, 2039	—	—	—		—
11918655	Feb 6, 2039	—	—	Yes		—
12324838	Feb 6, 2039	—	—	Yes	—	—

#002 — 1MG/SPRAY

RLD

8 patents0 exclusivities▾

SPRAY;NASAL | Approved: Mar 5, 2025