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Last Updated: December 7, 2023

Clobetasol propionate - Generic Drug Details

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What are the generic sources for clobetasol propionate and what is the scope of patent protection?

Clobetasol propionate is the generic ingredient in twelve branded drugs marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Mylan, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Fougera Pharms, Hikma, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Cadila, Epic Pharma Llc, Galderma Labs Lp, Novel Labs Inc, Taro Pharms, Galderma Labs, Macleods Pharms Ltd, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, and Apotex, and is included in ninety-five NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has forty-eight patent family members in twenty-two countries.

There are eleven drug master file entries for clobetasol propionate. Forty-six suppliers are listed for this compound.

Summary for clobetasol propionate

International Patents:	48
US Patents:	6
Tradenames:	12
Applicants:	39
NDAs:	95
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	66
Patent Applications:	6,045
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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

Drug Sales Revenue Trends 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
GEN İlaç ve Sağlık Ürünleri A.Ş.	Phase 2
Monitor CRO	Phase 2
Combined Military Hospital Abbottabad	Phase 1

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

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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
Saptalis Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	211494-001	Oct 2, 2019	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Mid Atlantic	CLOBETASOL PROPIONATE	clobetasol propionate	SHAMPOO;TOPICAL	078854-001	Jun 7, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	EMBELINE	clobetasol propionate	GEL;TOPICAL	076141-001	Apr 12, 2002	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fougera Pharms	TEMOVATE	clobetasol propionate	GEL;TOPICAL	020337-001	Apr 29, 1994		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	GEL;TOPICAL	075279-001	May 28, 1999	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Mid Atlantic	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	078223-001	Dec 4, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	209147-001	Sep 22, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 clobetasol propionate

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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	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	⤷ Try a Trial	⤷ Try a Trial
Mylan	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Try a Trial	⤷ Try a Trial
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for clobetasol propionate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3267978	COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)	⤷ Try a Trial
South Africa	200702702	Microemulsion & sub-micron emulsion process & compositions	⤷ Try a Trial
Japan	4972553		⤷ Try a Trial
Spain	2861374		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2016145407		⤷ Try a Trial
Canada	2756674	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)	⤷ Try a Trial
Poland	1796636		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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