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EPHEDRINE SULFATE

NDA

EPHEDRINE SULFATE | N213994 | PH HEALTH LTD

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

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10869845

Jan. 22, 2040

12029710

Jan. 22, 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
PH Health Limited v. Fresenius Kabi USA, LLC 1:2025cv01096 1 patentANDA 219991ephedrine sulfate	D. Del.	2025-08-29	Terminated 2025-11-25	—

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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 20, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/10ML (5MG/ML)

RLDAP2

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 16, 2020

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10869845	Jan 22, 2040	—	—	Yes	—	—

#002 — 25MG/5ML (5MG/ML)

RLDAP2

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 22, 2022