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EMERPHED

NDA

EPHEDRINE SULFATE | N213407 | NEXUS PHARMACEUTICALS LLC

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

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Today

May. 16, 2040

May. 16, 2040

May. 16, 2040

May. 16, 2040

May. 16, 2040

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

4 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
NEXUS PHARMACEUTICALS, LLC v. SABA ILAC SANAYI VE TICARET A.S. 2:2025cv14927 4 patentsANDA 218622ephedrine sulfate	D.N.J.	2025-08-26	Active	—
Nexus Pharmaceuticals, LLC v. Hikma Pharmaceuticals USA Inc. et al 1:2025cv00018 3 patentsANDA 217721ephedrine sulfate	D. Del.	2025-01-06	Terminated 2026-01-28	—
NEXUS PHARMACEUTICALS, INC. v. SOMERSET PHARMA, LLC 1:2023cv01248 2 patentsANDA 218113ephedrine sulfate	D.N.J.	2023-03-03	Terminated 2024-12-24	—
Nexus Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC 1:2022cv01233 1 patentephedrine sulfate	D. Del.	2022-09-21	Active	—

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 Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

EMBIO LTDEPHEDRINE SULFATE USP

DMF 326972018

MALLADI DRUGS AND PHARMACEUTICALS LTDEPHEDRINE SULFATE

DMF 332712019

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveEPHEDRINE SULFATE

DMF 26471976

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 16, 2024	SUPPL -9	View Letter (PDF)
Apr 14, 2023	SUPPL -4	View Letter (PDF)
Apr 20, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/10ML (5MG/ML)

RLDAP1

5 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 17, 2020

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11090278	May 16, 2040	—	—	—		—
11241400	May 16, 2040	—	—	—		—
11464752	May 16, 2040	—	—	Yes	—	—
11478436	May 16, 2040	—	—	—		—
11571398	May 16, 2040	—	—	—		—

#002 — 25MG/5ML (5MG/ML)

RLD

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 28, 2023