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DIFELIKEFALIN ACETATE

ANDA

DIFELIKEFALIN ACETATE | A220919 | QILU PHARMACEUTICAL HAINAN CO LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: KORSUVA(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Vifor Fresenius Medical Care Renal Pharma Ltd. et al v. Gland Pharma Limited et al 1:2025cv01382 12 patentsANDA 220918, 220939, 220919difelikefalin acetate	D. Del.	2025-11-13	Active	—

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

API Supply Chain8 active DMFs

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

SUZHOU YIFAN PHARMACEUTICAL CO LTDDIFELIKEFALIN ACETATE

DMF 431952025

CIPLA LTDDIFELIKEFALIN ACETATE

DMF 377122023

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDDIFELIKEFALIN ACETATE

DMF 385112023

ALP PHARM BEIJING CO LTDDIFELIKEFALIN ACETATE

DMF 386452023

MSN LIFE SCIENCES PRIVATE LTDDIFELIKEFALIN ACETATE

DMF 405372024

WISDOM PHARMACEUTICAL CO LTDDIFELIKEFALIN ACETATE

DMF 413412025

NEULAND LABORATORIES LTDDIFELIKEFALIN ACETATE

DMF 415032025

HYBIO PHARMACEUTICAL CO LTDDIFELIKEFALIN ACETATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 422662025

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

Products (1)

#001 — EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 31, 2026

No patent or exclusivity listings for this strength.