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Last Updated: May 1, 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, and Apotex, and is included in ninety-six 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. Thirty-nine suppliers are listed for this compound.

Summary for CLOBETASOL PROPIONATE

International Patents:	48
US Patents:	6
Tradenames:	12
Applicants:	38
NDAs:	96
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	39
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
Monitor CRO	Phase 2
GEN İlaç ve Sağlık Ürünleri A.Ş.	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
Prinston Inc	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	213139-001	Feb 8, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	CLOBETASOL PROPIONATE (EMOLLIENT)	clobetasol propionate	CREAM;TOPICAL	075733-001	Aug 22, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	CORMAX	clobetasol propionate	CREAM;TOPICAL	074220-001	May 16, 1997	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	EMBELINE	clobetasol propionate	SOLUTION;TOPICAL	074222-001	Dec 6, 1995	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985		DISCN	Yes	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
Zydus Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	210199-001	Oct 27, 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
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
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
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ 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
>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
Eurasian Patent Organization	201791921	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИД	⤷ Try a Trial
Canada	2756674	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)	⤷ Try a Trial
European Patent Office	1796636	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)	⤷ Try a Trial
South Korea	20170123335	코르티코스테로이드를 포함하는 국소용 조성물	⤷ Try a Trial
Japan	4972553		⤷ Try a Trial
Spain	2861374		⤷ 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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