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Last Updated: April 27, 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
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
Amneal	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	211256-001	Dec 26, 2018	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	200302-001	Jul 2, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	074249-001	Jul 8, 1996	AB1	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	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
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
>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	101243526		⤷ Try a Trial
Australia	2005279704	Microemulsion & sub-micron emulsion process & compositions	⤷ Try a Trial
Japan	2013503203		⤷ Try a Trial
Brazil	PI0514806	composições e processo de microemulsão e emulsão sub-mìcron	⤷ Try a Trial
Eurasian Patent Organization	037380	КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩАЯ КОРТИКОСТЕРОИД (TOPICAL COMPOSITION COMPRISING A CORTICOSTEROID)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.