Clobetasol propionate - Generic Drug Details

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What are the generic drug sources for clobetasol propionate and what is the scope of freedom to operate?

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, Beach Prods, 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:	41
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

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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
Mylan	IMPEKLO	clobetasol propionate	LOTION;TOPICAL	213691-001	May 19, 2020		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	200302-001	Jul 2, 2012	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Eyenovia	CLOBETASOL PROPIONATE	clobetasol propionate	SUSPENSION/DROPS;OPHTHALMIC	218158-001	Mar 4, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Amneal	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	211256-001	Dec 26, 2018	AB1	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Epic Pharma Llc	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	211348-001	Oct 26, 2018		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Chartwell Rx	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	211207-001	Mar 26, 2021		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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	⤷ Subscribe	⤷ Subscribe
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	⤷ Subscribe	⤷ Subscribe
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Subscribe	⤷ Subscribe
Norvium Bioscience	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	⤷ Subscribe	⤷ Subscribe
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985	⤷ Subscribe	⤷ Subscribe
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990	⤷ Subscribe	⤷ Subscribe
>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
Spain	2861374		⤷ Subscribe
Brazil	112017024000	suspensão aquosa contendo nano partículas de glucocorticosteroide	⤷ Subscribe
Israel	255452	תרחיף מימי המכיל ננוחלקיקים של גלוקוקורטיקוסטירואיד (Aqueous suspension containing nanoparticles of glucocorticosteroid)	⤷ Subscribe
Australia	2016262185	Aqueous suspension agent comprising glucocorticosteroid nanoparticles	⤷ Subscribe
European Patent Office	3267978	COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)	⤷ Subscribe
Japan	6856525		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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