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Last Updated: May 20, 2024

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, Epic Pharma Llc, Zydus Lifesciences, Galderma Labs Lp, Macleods Pharms Ltd, Novel Labs Inc, Galderma Labs, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, Apotex, and Formosa, and is included in ninety-eight NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has seventy-one patent family members in twenty-five countries.

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

Summary for CLOBETASOL PROPIONATE

International Patents:	71
US Patents:	8
Tradenames:	12
Applicants:	39
NDAs:	98
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	40
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

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
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
Pai Holdings Pharm	CLOBETASOL PROPIONATE (EMOLLIENT)	clobetasol propionate	CREAM;TOPICAL	209411-001	Aug 21, 2017		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	211074-001	Oct 15, 2018	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	EMBELINE	clobetasol propionate	GEL;TOPICAL	076141-001	Apr 12, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	208933-001	Mar 20, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Formosa	CLOBETASOL PROPIONATE	clobetasol propionate	SUSPENSION/DROPS;OPHTHALMIC	218158-001	Mar 4, 2024		RX	Yes	Yes	⤷ 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 Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	⤷ Try a Trial	⤷ Try a Trial
Mylan	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007	⤷ Try a Trial	⤷ Try a Trial
Mylan	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	⤷ Try a Trial	⤷ Try a Trial
Fougera Pharms	TEMOVATE	clobetasol propionate	CREAM;TOPICAL	019322-001	Dec 27, 1985	⤷ 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	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ 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
South Korea	20180004164	글루코코르티코스테로이드의 나노미립자를 함유하는 수성 현탁액제	⤷ Try a Trial
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	⤷ Try a Trial
Ukraine	121232	КОМПОЗИЦІЇ ДЛЯ МІСЦЕВОГО ЗАСТОСУВАННЯ, ЩО МІСТЯТЬ КОРТИКОСТЕРОЇД (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)	⤷ Try a Trial
China	101048136	Microemulsion and sub-micron emulsion process and compositions	⤷ Try a Trial
Canada	2985171	AGENT AQUEUX DE SUSPENSION COMPRENANT DES NANOPARTICULES DE GLUCOCORTICOSTEROIDE (AQUEOUS SUSPENSION CONTAINING NANOPARTICLES OF GLUCOCORTICOSTEROID)	⤷ Try a Trial
Taiwan	200624124	Micro emulsion and sub-micron emulsion process and composition	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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