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. 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	—
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.015%

RLD

12 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jan 23, 2012

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8278292	Jul 6, 2027	—	—	Yes	—	—
8372827	Dec 18, 2026	—	—	Yes	—	—
8372828	Dec 18, 2026	—	—	Yes	—	—
8377919	Dec 18, 2026	—	—	Yes	—	—
8536163	Dec 18, 2026	—	—	—		—
8716271	Dec 18, 2026	—	—	—		—
8735375	Dec 18, 2026	—	—	—		—
9789078	May 15, 2033	—	—	—		—
9820959	Dec 18, 2026	—	—	Yes		—
9833428	Dec 18, 2026	—	—	Yes	—	—
9833429	Dec 18, 2026	—	—	Yes	—	—
9861603	Dec 18, 2026	—	—	—		—

#002 — 0.05%

RLD

11 patents0 exclusivities▾

GEL;TOPICAL | Approved: Jan 23, 2012