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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

INGENOL MEBUTATE

ANDA

Tentative Approval

INGENOL MEBUTATE | A209086 | ACTAVIS LABS

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
LEO Pharma A/S et al v. Actavis Laboratories UT, Inc. 1:2017cv01752 3 patentsANDA 208807, 209086ingenol mebutate	D. Del.	2017-12-06	Terminated 2018-04-03	—
LEO Pharma A/S et al v. Actavis Laboratories UT, Inc. 1:2016cv00333 8 patentsANDA 208807, 209086ingenol mebutate	D. Del.	2016-05-06	Terminated 2018-08-16	—

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 2, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

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GEL; TOPICAL | TA Date: 2018-02-06 00:00:00

No patent or exclusivity listings for this strength.