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 Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Mylan, Aleor Dermaceuticals, Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Rising, Teligent, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms Inc, Fougera Pharms, Akorn, Encore Dermat, Perrigo Co, Actavis Mid Atlantic, Cadila, Galderma Labs Lp, Novel Labs Inc, Galderma Labs, Macleods Pharms Ltd, Saptalis Pharms, Tolmar, Wockhardt Bio Ag, Apotex, and Paddock Llc, and is included in eighty-nine NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has seventy-eight patent family members in twenty-seven countries.

There are fourteen drug master file entries for clobetasol propionate. Fifty suppliers are listed for this compound.

Summary for clobetasol propionate

International Patents:	78
US Patents:	7
Tradenames:	12
Applicants:	35
NDAs:	89
Drug Master File Entries:	14
Suppliers / Packagers:	50
Bulk Api Vendors:	66
Clinical Trials:	54
Patent Applications:	6,885
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

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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
Cairo University	Phase 3
Skane University Hospital	Phase 2/Phase 3
Malmö University	Phase 2/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

Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
IMPOYZ	CREAM;TOPICAL	clobetasol propionate	209483	2019-12-06
OLUX E	AEROSOL, FOAM;TOPICAL	clobetasol propionate	022013	2010-02-25
CLOBEX	SPRAY;TOPICAL	clobetasol propionate	021835	2008-09-29
CLOBEX	SHAMPOO;TOPICAL	clobetasol propionate	021644	2008-01-09
CLOBEX	LOTION;TOPICAL	clobetasol propionate	021535	2006-03-27
OLUX	AEROSOL, FOAM;TOPICAL	clobetasol propionate	021142	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
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	SPRAY;TOPICAL	208842-001	Mar 26, 2018	AT	RX	No	No	Start Trial	Start Trial				Start Trial
Aleor Dermaceuticals	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	213291-001	Jan 27, 2020	AB1	RX	No	No	Start Trial	Start Trial				Start Trial
Akorn	EMBELINE E	clobetasol propionate	CREAM;TOPICAL	075325-001	Dec 24, 1998	AB2	RX	No	No	Start Trial	Start Trial				Start Trial
Fougera Pharms	TEMOVATE	clobetasol propionate	GEL;TOPICAL	020337-001	Apr 29, 1994		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	074248-001	Jul 12, 1996	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	AB	RX	Yes	Yes	Start Trial	Start Trial				Start 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	Start Trial	Start Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	Start Trial	Start Trial
Mylan	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	Start Trial	Start Trial
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	Start Trial	Start Trial
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	Start Trial	Start Trial
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985	Start Trial	Start 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	Estimated Expiration
China	1171579	Start Trial
Norway	20006471	Start Trial
China	101048136	Start Trial
Russian Federation	2193388	Start Trial
Israel	181632	Start Trial
Germany	69941497	Start Trial
>Country	>Patent Number	>Estimated Expiration

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