Viewing data from:

EFINACONAZOLE

ANDA

EFINACONAZOLE | A212027 | ALEMBIC PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: JUBLIA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BAUSCH HEALTH US, LLC et al v. ALEOR DERMACEUTICALS LTD. 3:2020cv02735 3 patentsANDA 212027efinaconazole	D.N.J.	2020-03-12	Terminated 2020-05-14	—

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

API Supply Chain17 active DMFs1 inactive

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

KAKEN PHARMACEUTICAL CO LTDEFINACONAZOLE

DMF 270812013

MAITHRI DRUGS PRIVATE LTDEFINACONAZOLE [ROUTE CODE 'EC']

DMF 304202016

WAVELENGTH ENTERPRISES LTDEFINACONAZOLE

DMF 305382016

ALIVUS LIFE SCIENCES LTDEFINACONAZOLE

DMF 308922016

VIRUPAKSHA ORGANICS LTDEFINACONAZOLE

DMF 313662017

LUPIN MANUFACTURING SOLUTIONS LTDEFINACONAZOLE

DMF 315032017

DIPHARMA FRANCIS SRLEFINACONAZOLE

DMF 319182017

PROCOS SPAEFINACONAZOLE

DMF 319332017

HARMAN FINOCHEM LTDEFINACONAZOLE

DMF 320332017

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDEFINACONAZOLE

DMF 320762017

SOLARA ACTIVE PHARMA SCIENCES LTDEFINACONAZOLE

DMF 322862017

CIPLA LTDEFINACONAZOLE

DMF 323172018

MACLEODS PHARMACEUTICALS LTDEFINACONAZOLE

DMF 323952018

TOPHARMAN SHANDONG CO LTDEFINACONAZOLE

DMF 324792018

MATRIX PHARMACORP PRIVATE LTDEFINACONAZOLE

DMF 343762019

VIWIT PHARMACEUTICAL CO LTDEFINACONAZOLE

DMF 366652022

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDEFINACONAZOLE

DMF 397392024

VIWIT PHARMACEUTICAL CO LTDInactiveEFINACONAZOLE

DMF 344222020

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 6, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Feb 23, 2026

No patent or exclusivity listings for this strength.