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, 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, Apotex, and Formosa, 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:	39
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
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
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
Zydus Lifesciences	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	205249-001	Sep 24, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt Bio Ag	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	075205-001	Nov 13, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Torrent	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	212926-001	Oct 25, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	CLOBETASOL PROPIONATE	clobetasol propionate	SHAMPOO;TOPICAL	213290-001	May 18, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	TEMOVATE	clobetasol propionate	GEL;TOPICAL	020337-001	Apr 29, 1994		DISCN	Yes	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	CREAM;TOPICAL	019322-001	Dec 27, 1985	⤷ Sign Up	⤷ Sign Up
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
Mylan	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	⤷ Sign Up	⤷ Sign Up
Mylan	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007	⤷ 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
Israel	181632	תכשירים ותהליך להכנת מיקרואמולסיה ואמולסיה תת-מיקרונים (Microemulsion and sub-micron emulsion process and compositions)	⤷ Sign Up
Argentina	051197	UN PROCEDIMIENTO PARA OBTENER UNA MICROEMULSION Y SUB-MICRON EMULSION Y COMPOSICIONES	⤷ Sign Up
Australia	2016262185	Aqueous suspension agent comprising glucocorticosteroid nanoparticles	⤷ Sign Up
Portugal	3295943		⤷ Sign Up
Hungary	E061418		⤷ Sign Up
Israel	255452	תרחיף מימי המכיל ננוחלקיקים של גלוקוקורטיקוסטירואיד (Aqueous suspension containing nanoparticles of glucocorticosteroid)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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