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AKOVAZ

NDA

EPHEDRINE SULFATE | N208289 | EXELA PHARMA SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
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

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/ML (50MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 29, 2016

No patent or exclusivity listings for this strength.

#002 — 25MG/5ML (5MG/ML)

RLDAP3

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 2, 2021