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EPINEPHRINE

NDA

EPINEPHRINE | N205029 | BPI LABS LLC

5 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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Belcher Pharmaceuticals, LLC v. Hospira, Inc. 1:2019cv01854	D. Del.	2019-10-03	Terminated 2022-08-10	—
Belcher Pharmaceuticals, LLC v. International Medication Systems, Limited 1:2018cv00960 1 patentEpinephrine	D. Del.	2018-06-28	Terminated 2022-03-28	—
Belcher Pharmaceuticals, LLC v. Hospira, Inc. 1:2017cv00775	D. Del.	2017-06-19	Terminated 2020-04-20	—

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

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Belcher Pharmaceuticals, LLC FDA-2017-P-3352 · 5 docket documents Belcher Pharmaceuticals, LLC filed this petition on May 25, 2017, requesting that the FDA amend the sulfite warning requirement in 21 C.F.R. 201.22(c) for sulfite-containing epinephrine for injection used in emergency situations to acknowledge the availability of sulfite-free epinephrine products an	Other	2017-05-26	Open	Belcher Pharmaceuticals, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

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

12 letters from Drugs@FDA

Date	Submission	Document
Sep 30, 2025	SUPPL -17	View Letter (PDF)
Jul 7, 2025	SUPPL -15	View Letter (PDF)
May 7, 2024	SUPPL -12	View Letter (PDF)
Feb 23, 2024	SUPPL -13	View Letter (PDF)
May 15, 2023	SUPPL -10	View Letter (PDF)
Mar 27, 2023	SUPPL -9	View Letter (PDF)
Sep 15, 2021	SUPPL -6	View Letter (PDF)
Jun 24, 2021	SUPPL -8	View Letter (PDF)
May 19, 2016	SUPPL -4	View Letter (PDF)
Feb 12, 2016	SUPPL -2	View Letter (PDF)
Oct 26, 2015	SUPPL -1	View Letter (PDF)
Jul 31, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 1MG/ML (1MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | Approved: Jul 29, 2014

No patent or exclusivity listings for this strength.

#002 — 10MG/10ML (1MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Feb 4, 2022

#003 — 1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 12, 2023

#004 — 30MG/30ML (1MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Feb 14, 2024

#005 — 1MG/ML (1MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 4, 2024