Viewing data from:

ZURNAI (AUTOINJECTOR)

NDA

NALMEFENE HYDROCHLORIDE | N218590 | KNOA PHARMA LLC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2026

2027

2028

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2040

Today

11857547

Nov. 5, 2039

11865112

Nov. 5, 2039

Aug. 7, 2027

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCNALMEFENE HYDROCHLORIDE

DMF 156632001

RUSAN PHARMA LTDNALMEFENE HYDROCHLORIDE

DMF 343672019

SICHUAN QINGMU PHARMACEUTICAL CO LTDNALMEFENE HYDROCHLORIDE

DMF 367512022

PURISYS LLCNALMEFENE HYDROCHLORIDE DRUG SUBSTANCE

DMF 397672024

SANOFI SAInactiveNALMEFENE HYDROCHLORIDE

DMF 54841984

NV ORGANONInactiveNALMEFENE HYDROCHLORIDE

DMF 56421984

TASMANIAN ALKALOIDS PROPRIETARY LTDInactiveNALMEFENE HYDROCHLORIDE

DMF 85071990

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 15, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)

RLD

2 patents1 exclusivity▴

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Aug 7, 2024

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11857547	Nov 5, 2039	—	—	Yes	—	—
11865112	Nov 5, 2039	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
NP	Aug 7, 2027	Active

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Nalmefene hydrochloride (ZURNAI autoinjector) applicant changed from Purdue Pharma LP to KNOA Pharma.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA Pharma LLC became the listed applicant for nalmefene hydrochloride autoinjector (Zurnai, NDA 218590) following a transfer from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC