TOPICORT Drug Patent Profile

When do Topicort patents expire, and when can generic versions of Topicort launch?

Topicort is a drug marketed by Taro Pharm Inds Ltd and Taro Pharms and is included in ten NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Topicort

A generic version of TOPICORT was approved as desoximetasone by PADAGIS ISRAEL on July 1^st, 2003.

Summary for TOPICORT

International Patents:	4
US Patents:	2
Applicants:	2
NDAs:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	4
Patent Applications:	6,402
Drug Prices:	Drug price information for TOPICORT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOPICORT
What excipients (inactive ingredients) are in TOPICORT?	TOPICORT excipients list
DailyMed Link:	TOPICORT at DailyMed

See drug prices for TOPICORT

See drug sales revenues for TOPICORT

Recent Clinical Trials for TOPICORT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Psoriasis Treatment Center of Central New Jersey	Phase 4
Taro Pharmaceuticals USA	Phase 4

See all TOPICORT clinical trials

Pharmacology for TOPICORT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TOPICORT

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for TOPICORT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOPICORT	Topical Spray	desoximetasone	0.25%	204141	1	2013-12-18

US Patents and Regulatory Information for TOPICORT

TOPICORT is protected by two US patents.

Patents protecting TOPICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	CREAM;TOPICAL	073210-001	Nov 30, 1990	AB	RX	No	Yes
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	OINTMENT;TOPICAL	074286-001	Jun 7, 1996		DISCN	No	No
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	GEL;TOPICAL	074904-001	Jul 14, 1998	AB	RX	No	Yes
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018763-001	Sep 30, 1983		DISCN	Yes	No
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	CREAM;TOPICAL	073193-001	Nov 30, 1990	AB	RX	No	Yes
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	CREAM;TOPICAL	017856-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TOPICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro Pharms	TOPICORT	desoximetasone	SPRAY;TOPICAL	204141-001	Apr 11, 2013

International Patents for TOPICORT

See the table below for patents covering TOPICORT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1888026	PREPARATION LIQUIDE STABLE COMPRENANT DE LA DESOXYMETASONE ET DU MYRISTATE ISOPROPYLIQUE A TENEUR REDUITE EN IMPURETES OXYDEES EN CAS DE STOCKAGE DE LONGUE DUREE (A STABLE LIQUID FORMULATION COMPRISING DESOXIMETASONE AND ISOPROPYL MYRISTATE WITH REDUCED OXIDIZED IMPURITY DURING LONG-TERM STORAGE)
Canada	2609579	PREPARATION LIQUIDE STABLE COMPRENANT DE LA DESOXYMETASONE ET DU MYRISTATE ISOPROPYLIQUE A TENEUR REDUITE EN IMPURETES OXYDEES EN CAS DE STOCKAGE DE LONGUE DUREE (STABLE LIQUID DESOXIMETASONE COMPOSITIONS WITH REDUCED OXIDIZED IMPURITY)
Israel	187666	הרכב נוזלי ויציב של דסוקסימטאסון ואיזופרופיל מיריסטט עם רמת זיהומים מחומצנים פחותה במהלך איחסון ארוך טווח (Stable liquid formulation comprising desoximetasone and isopropyl myristate with reduced oxidized impurity during long-term storage)
World Intellectual Property Organization (WIPO)	2006130510