Clobetasol propionate - Generic Drug Details

✉ Email this page to a colleague

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Xiromed	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	209701-001	Apr 17, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	075391-001	Feb 8, 1999	AT	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
Norvium Bioscience	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	TEMOVATE E	clobetasol propionate	CREAM;TOPICAL	020340-001	Jun 17, 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

Subscribe to access the full database, or Sign Up
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
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	⤷ Sign Up	⤷ Sign Up
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for clobetasol propionate

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
European Patent Office	3267978	COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)	⤷ Sign Up
Eurasian Patent Organization	037380	КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩАЯ КОРТИКОСТЕРОИД (TOPICAL COMPOSITION COMPRISING A CORTICOSTEROID)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011026076		⤷ Sign Up
Israel	181632	תכשירים ותהליך להכנת מיקרואמולסיה ואמולסיה תת-מיקרונים (Microemulsion and sub-micron emulsion process and compositions)	⤷ Sign Up
Taiwan	200624124	Micro emulsion and sub-micron emulsion process and composition	⤷ Sign Up
Spain	2637447		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.