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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

308 trials from ClinicalTrials.gov — 23 recruiting, 2 active, 207 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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 → 2031-06-30
Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock NCT07775001	N/A	Active	Nishtar Medical University	66	2026-02-18 → 2026-09-17
Exparel Injection Effect on Postoperative Opioid Usage NCT04085913	Early Phase 1	By Invitation	University of Missouri-Columbia	100	2019-09-30 → 2025-07
Split Face Study of the Duration of Local Anesthetics - Fifth Arm NCT07724418	Phase 4	Not Yet Recruiting	Weill Medical College of Cornell University	50	2026-08-01 → 2027-06-30
Vasopressor Agents in Pulmonary Hypertension Crisis NCT07667829	N/A	Not Yet Recruiting	China National Center for Cardiovascular Diseases	75	2026-06 → 2029-01-31
This is a Study That Aims to Estimate the Effect of Maternal Body Mass Index on the Prophylactic Dose of Norepinephrine Infusion for Preventing Hypotension in Parturient After Spinal Anesthesia NCT07706426	N/A	Not Yet Recruiting	Ain Shams University	80	2026-07-09 → 2027-04-20
Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy NCT07714915	N/A	Not Yet Recruiting	Recep Tayyip Erdogan University Training and Research Hospital	38	2026-08-12 → 2026-10-15
A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)NCT07793942	Phase 2	Not Yet Recruiting	Merck Sharp & Dohme LLC	480	2026-10-27 → 2030-07-28
Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision NCT07753629	N/A	Not Yet Recruiting	Seoul National University Hospital	58	2026-08-07 → 2028-07-31
Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canalf and iPACK Blocks in Total Knee Arthroplasty NCT07097493	Phase 4	Not Yet Recruiting	Wake Forest University Health Sciences	90	2027-02 → 2027-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs

Highest NADAC/Unit

$119.35

per ea

Lowest NADAC/Unit

$112.37

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00115169530EPINEPHRINE 0.15 MG AUTO-INJCT	$119.35	EA	Generic	—	2026-10-21
00115169549EPINEPHRINE 0.15 MG AUTO-INJCT	$119.35	EA	Generic	—	2026-10-21
00115169430EPINEPHRINE 0.3 MG AUTO-INJECT	$112.37	EA	Generic	—	2026-10-21
00115169449EPINEPHRINE 0.3 MG AUTO-INJECT	$112.37	EA	Generic	—	2026-10-21

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	$107.71	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
00115-1694-49EPINEPHRINE (EQV-ADRENACLICK) 0.3MG/0.3ML INJ	$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
00115-1695-49EPINEPHRINE (EQV-ADRENACLICK) 0.15MG/0.15ML	$177.18	FSS	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.

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

DMF 431562025

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

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