CLOBEX Drug Patent Profile

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Which patents cover Clobex, and what generic alternatives are available?

Clobex is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs.

The generic ingredient in CLOBEX 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 Clobex

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

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Summary for CLOBEX

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	14
Patent Applications:	4,476
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CLOBEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOBEX
What excipients (inactive ingredients) are in CLOBEX?	CLOBEX excipients list
DailyMed Link:	CLOBEX at DailyMed

Drug patent expirations by year for CLOBEX

Recent Clinical Trials for CLOBEX

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

Sponsor	Phase
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)	Phase 1
MC2 Therapeutics	Phase 1
University of California, San Francisco	Phase 4

See all CLOBEX clinical trials

Pharmacology for CLOBEX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for CLOBEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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

US Patents and Regulatory Information for CLOBEX

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CLOBEX

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	⤷ Sign Up	⤷ Sign Up
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CLOBEX

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1695691	Composition moussante pour le lavage et le traitement des cheveux (Foaming composition for hair cleaning and hair treatment)	⤷ Sign Up
Austria	241960		⤷ Sign Up
Russian Federation	2162688	КОМПОЗИЦИЯ В ФОРМЕ ЖИДКОЙ ЭМУЛЬСИИ ТИПА МАСЛО-В-ВОДЕ ДЛЯ НАРУЖНОГО НАНЕСЕНИЯ (COMPOSITION IN LIQUID FORM OF OIL-IN-WATER TYPE FOR EXTERNAL APPLICATION)	⤷ Sign Up
South Africa	200006073	Foaming composition for hair care.	⤷ Sign Up
Portugal	832647		⤷ Sign Up
Denmark	1087747		⤷ Sign Up
Poland	198663		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration