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, Norvium Bioscience, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Speclt, 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, Mylan, Macleods Pharms Ltd, Novel Labs Inc, Galderma Labs, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, and Eyenovia, 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:	40
NDAs:	98
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	69
Patent Applications:	5,812
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
Kantonsspital Winterthur KSW	N/A
Dermatology Consulting Services, PLLC	Phase 4
October 6 University	Phase 3

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
Padagis Israel	CLOBETASOL PROPIONATE	clobetasol propionate	SHAMPOO;TOPICAL	090974-001	Aug 9, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	074331-001	Dec 15, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	210199-001	Oct 27, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	CLOBETASOL PROPIONATE	clobetasol propionate	SPRAY;TOPICAL	208125-001	Mar 26, 2018	AT	RX	No	No	⤷ 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 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	⤷ Sign Up	⤷ Sign Up
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
Norvium Bioscience	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985	⤷ Sign Up	⤷ Sign Up
>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
Brazil	PI0514806	composições e processo de microemulsão e emulsão sub-mìcron	⤷ Sign Up
Australia	2016262185	Aqueous suspension agent comprising glucocorticosteroid nanoparticles	⤷ Sign Up
Taiwan	201701882	Aqueous suspension containing nano particles of GLUCOCORTICOIDS	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006024095		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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