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INGENOL MEBUTATE

ANDA

INGENOL MEBUTATE | A209019 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
LEO Pharma A/S et al v. Perrigo UK Finco Limited Partnership, et al 1:2017cv01753 3 patentsANDA 209018, 209019ingenol mebutate (ingenol-3-angelate)	D. Del.	2017-12-06	Terminated 2018-04-09	—

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

API Supply Chain1 active DMF2 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SICHUAN XIELI PHARMACEUTICAL CO LTDINGENOL MEBUTATE

DMF 295562015

INDENA SPAInactiveINGENOL MEBUTATE

DMF 287472014

DR REDDYS LABORATORIES LTDInactiveINGENOL MEBUTATE

DMF 301172015

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2019	ORIG -1	View Letter (PDF)
Nov 8, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jan 9, 2019

No patent or exclusivity listings for this strength.