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IVERMECTIN

ANDA

IVERMECTIN | A212485 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Arbor Pharmaceuticals, LLC v. Teva Pharmaceuticals USA, Inc. 1:2019cv00053 2 patentsANDA 212485ivermectin lotion	D. Del.	2019-01-09	Terminated 2019-09-10	—

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

API Supply Chain4 active DMFs3 inactive

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

HOVIONE PHARMASCIENCE LTDIVERMECTIN USP

DMF 213952008

ZHEJIANG HISUN PHARMACEUTICAL CO LTDIVERMECTIN USP

DMF 216242008

INDUSTRIALE CHIMICA SRLIVERMECTIN PH. FUR.

DMF 364942021

HEBEI MEIHE PHARMACEUTICAL CO LTDIVERMECTIN

DMF 385532023

HAIMEN PHARMACEUTICAL FACTORYInactiveIVERMECTIN, NON-STERILE BULK DRUG

DMF 127551997

SHANGHAI TONGREN PHARMACEUTICAL CO LTDInactiveIVERMECTIN

DMF 130371998

DELTA TECH LTDInactiveIVERMECTIN

DMF 176732004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 4, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Mar 21, 2022

No patent or exclusivity listings for this strength.