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NDA

EPINEPHRINE | N207534 | ADAMIS PHARMACEUTICALS CORP

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

11141540

Oct. 20, 2036

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Adamis Pharmaceuticals Corporation v. Belcher Pharmaceuticals, LLC 8:2018cv02379 2 patentsEpinephrine	FLMD	2018-09-26	Terminated 2019-07-29	—

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

4 letters from Drugs@FDA

Date	Submission	Document
Jun 30, 2021	SUPPL -12	View Letter (PDF)
Aug 27, 2020	SUPPL -8	View Letter (PDF)
Oct 1, 2018	SUPPL -3	View Letter (PDF)
Jun 16, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.3MG/0.3ML (0.3MG/0.3ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Jun 15, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11141540	Oct 20, 2036	—	—	Yes		—

#002 — 0.15MG/0.3ML (0.15MG/0.3ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Sep 27, 2018