Viewing data from:

EPHEDRINE SULFATE

ANDA

EPHEDRINE SULFATE | A217721 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AKOVAZ(TE code: AP3)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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	—

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

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.

Products (1)

#001 — 25MG/5ML (5MG/ML)

AP3

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 11, 2024

No patent or exclusivity listings for this strength.