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 Aleor Dermaceuticals, Glenmark Pharms Ltd, Ingenus Pharms Llc, Padagis Israel, Taro, Mylan, Amneal, Aurobindo Pharma Usa, Cosette Pharms, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Fougera Pharms, Akorn, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Cadila, Galderma Labs Lp, Novel Labs Inc, Taro Pharms, Galderma Labs, Macleods Pharms Ltd, Prinston Inc, Saptalis Pharms, Solaris Pharma Corp, Tolmar, Wockhardt Bio Ag, and Apotex, and is included in ninety-five 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 eighty patent family members in twenty-seven countries.

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

Summary for clobetasol propionate

International Patents:	80
US Patents:	7
Tradenames:	12
Applicants:	37
NDAs:	95
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	61
Patent Applications:	6,672
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
Fundación Eduardo Anitua	Phase 3
University of South Alabama	Phase 2/Phase 3
Patty Brisben Foundation For Women's Sexual Health	Phase 4

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
Encube	CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	212982-001	Aug 28, 2020	AB1	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Akorn	CORMAX	clobetasol propionate	CREAM;TOPICAL	074220-001	May 16, 1997	AB1	RX	No	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Akorn	EMBELINE E	clobetasol propionate	CREAM;TOPICAL	075325-001	Dec 24, 1998	AB2	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Fougera Pharms	TEMOVATE E	clobetasol propionate	CREAM;TOPICAL	020340-001	Jun 17, 1994		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	SPRAY;TOPICAL	021835-001	Oct 27, 2005	See Plans and Pricing	See Plans and Pricing
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	See Plans and Pricing	See Plans and Pricing
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	See Plans and Pricing	See Plans and Pricing
Fougera Pharms	TEMOVATE	clobetasol propionate	CREAM;TOPICAL	019322-001	Dec 27, 1985	See Plans and Pricing	See Plans and Pricing
Mylan	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	See Plans and Pricing	See Plans and Pricing
Mylan	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007	See Plans and Pricing	See Plans and Pricing
>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
France	2761600	COMPOSITION MOUSSANTE POUR LE LAVAGE ET LE TRAITEMENT DES CHEVEUX ET/OU DU CUIR CHEVELU A BASE D'UN PRINCIPE ACTIF, D'UN TENSIOACTIF ANIONIQUE, D'UN TENSIOACTIF AMPHOTERE ET D'UN AGENT PROPENETRANT	See Plans and Pricing
New Zealand	735341	Topical compositions comprising a corticosteroid	See Plans and Pricing
China	1306413		See Plans and Pricing
Germany	69928253		See Plans and Pricing
South Korea	101243526		See Plans and Pricing
South Korea	20200051854	코르티코스테로이드를 포함하는 국소용 조성물 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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