CLOBETASOL PROPIONATE Drug Patent Profile

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

Clobetasol Propionate is a drug marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Speclt, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms Ltd, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, Eyenovia, and Ani Pharms. and is included in eighty-one NDAs. There are two patents protecting this drug.

This drug has twenty-three patent family members in seventeen countries.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clobetasol Propionate

A generic version of CLOBETASOL PROPIONATE was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for CLOBETASOL PROPIONATE

International Patents:	23
US Patents:	2
Applicants:	35
NDAs:	81
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	69
Patent Applications:	4,476
Drug Prices:	Drug price information for CLOBETASOL PROPIONATE
Drug Sales Revenues:	Drug sales revenues for CLOBETASOL PROPIONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOBETASOL PROPIONATE
What excipients (inactive ingredients) are in CLOBETASOL PROPIONATE?	CLOBETASOL PROPIONATE excipients list
DailyMed Link:	CLOBETASOL PROPIONATE at DailyMed

See drug prices for CLOBETASOL PROPIONATE

See drug sales revenues for CLOBETASOL PROPIONATE

Recent Clinical Trials for CLOBETASOL PROPIONATE

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

Sponsor	Phase
Kantonsspital Winterthur KSW	N/A
Dermatology Consulting Services, PLLC	Phase 4
October 6 University	Phase 3

See all CLOBETASOL PROPIONATE clinical trials

Pharmacology for CLOBETASOL PROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for CLOBETASOL PROPIONATE

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for CLOBETASOL PROPIONATE

D07AD	Corticosteroids, very potent (group IV)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMPOYZ	Cream	clobetasol propionate	0.025%	209483	1	2019-12-06
OLUX E	Emulsion Foam	clobetasol propionate	0.05%	022013	1	2010-02-25
CLOBEX	Spray	clobetasol propionate	0.05%	021835	1	2008-09-29
CLOBEX	Topical Shampoo	clobetasol propionate	0.05%	021644	1	2008-01-09
CLOBEX	Lotion	clobetasol propionate	0.05%	021535	1	2006-03-27
OLUX	Topical Foam	clobetasol propionate	0.05%	021142	1	2005-06-27

US Patents and Regulatory Information for CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting CLOBETASOL PROPIONATE

FDA Regulatory Exclusivity protecting CLOBETASOL PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	CLOBETASOL PROPIONATE	clobetasol propionate	SPRAY;TOPICAL	208125-001	Mar 26, 2018	AT	RX	No	No
Fougera Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	074407-001	Feb 23, 1996	AB	RX	No	Yes
Pai Holdings Pharm	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	208667-001	Nov 29, 2016		DISCN	No	No
Zydus Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	210199-001	Oct 27, 2017	AB	RX	No	No
Glenmark Pharms Ltd	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	210190-001	Apr 18, 2018	AT	RX	No	No
Pai Holdings Pharm	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	208589-001	Jan 23, 2019		DISCN	No	No
Actavis Mid Atlantic	CLOBETASOL PROPIONATE	clobetasol propionate	SHAMPOO;TOPICAL	078854-001	Jun 7, 2011		DISCN	No	No

International Patents for CLOBETASOL PROPIONATE

See the table below for patents covering CLOBETASOL PROPIONATE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102268710
Mexico	2017014340	SUSPENSION ACUOSA QUE CONTIENE NANOPARTICULAS DE GLUCOCORTICOSTEROIDE. (AQUEOUS SUSPENSION AGENT COMPRISING GLUCOCORTICOSTEROID NANOPARTICLES.)
Japan	WO2016181935	グルココルチコステロイドのナノ微粒子を含有する水性懸濁液剤
Russian Federation	2017142694	ВОДНАЯ СУСПЕНЗИЯ, СОДЕРЖАЩАЯ НАНОЧАСТИЦЫ ГЛЮКОКОРТИКОСТЕРОИДА
Russian Federation	2747803	ВОДНАЯ СУСПЕНЗИЯ, СОДЕРЖАЩАЯ НАНОЧАСТИЦЫ ГЛЮКОКОРТИКОСТЕРОИДА (AQUEOUS SUSPENSION CONTAINING GLUCOCORTICOSTEROID NANOPARTICLES)
China	107613985	含有糖皮质激素的纳米微粒的水性悬浮液剂 (AQUEOUS SUSPENSION AGENT COMPRISING GLUCOCORTICOSTEROID NANOPARTICLES)
Brazil	112017024000	suspensão aquosa contendo nano partículas de glucocorticosteroide