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TWINJECT

NDA

EPINEPHRINE | N020800 | IMPAX LABORATORIES LLC

4 strengths0 unique patents0 unique exclusivities

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 | 4 NDCs

Highest NADAC/Unit

$119.40

per ea

Lowest NADAC/Unit

$113.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00115169530EPINEPHRINE 0.15 MG AUTO-INJCT	$119.40	EA	Generic	—	2026-06-17
00115169549EPINEPHRINE 0.15 MG AUTO-INJCT	$119.40	EA	Generic	—	2026-06-17
00115169430EPINEPHRINE 0.3 MG AUTO-INJECT	$113.12	EA	Generic	—	2026-06-17
00115169449EPINEPHRINE 0.3 MG AUTO-INJECT	$113.12	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$98.27

Highest Price

$177.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00115-1694-49EPINEPHRINE (EQV-ADRENACLICK) 0.3MG/0.3ML INJ	$177.18	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
00115-1694-49EPINEPHRINE (EQV-ADRENACLICK) 0.3MG/0.3ML INJ	$107.71	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
00115-1695-49EPINEPHRINE (EQV-ADRENACLICK) 0.15MG/0.15ML	$177.18	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
00115-1695-49EPINEPHRINE (EQV-ADRENACLICK) 0.15MG/0.15ML	$98.27	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027

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

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

15 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -54	View Letter (PDF)
Nov 21, 2024	SUPPL -52	View Letter (PDF)
Feb 5, 2021	SUPPL -40	View Letter (PDF)
Sep 13, 2018	SUPPL -35	View Letter (PDF)
May 19, 2016	SUPPL -34	View Letter (PDF)
Oct 22, 2014	SUPPL -30	View Letter (PDF)
Jul 28, 2014	SUPPL -27	View Letter (PDF)
Apr 24, 2014	SUPPL -24	View Letter (PDF)
Feb 3, 2011	SUPPL -20	View Letter (PDF)
Jan 8, 2007	SUPPL -11	View Letter (PDF)
Jul 15, 2005	SUPPL -6	View Letter (PDF)
Jul 8, 2005	SUPPL -7	View Letter (PDF)
Feb 23, 2005	SUPPL -5	View Letter (PDF)
Jun 1, 2004	SUPPL -1	View Letter (PDF)
Jun 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#003 — EQ 0.15MG/DELIVERY

RLDBX

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Nov 25, 2009

#004 — EQ 0.3MG/DELIVERY

RLDBX

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Nov 25, 2009

#001 — EQ 0.3MG/DELIVERY

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Approved: May 30, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 0.15MG/DELIVERY

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Approved: May 28, 2004