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 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:	66
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
GEN İlaç ve Sağlık Ürünleri A.Ş.	Phase 2
Monitor CRO	Phase 2
Combined Military Hospital Abbottabad	Phase 1

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
Taro	CLOBETASOL PROPIONATE	clobetasol propionate	GEL;TOPICAL	075279-001	May 28, 1999	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	CLOBETASOL PROPIONATE	clobetasol propionate	AEROSOL, FOAM;TOPICAL	210809-001	Feb 15, 2019	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	EMBELINE E	clobetasol propionate	CREAM;TOPICAL	075325-001	Dec 24, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	212926-001	Oct 25, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CORMAX	clobetasol propionate	CREAM;TOPICAL	074220-001	May 16, 1997		DISCN	No	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
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	TEMOVATE	clobetasol propionate	CREAM;TOPICAL	019322-001	Dec 27, 1985	⤷ 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	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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2473161	COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID)	⤷ Sign Up
China	107872972	包含皮质类固醇的外用组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)	⤷ Sign Up
Poland	3295943		⤷ Sign Up
Mexico	2017014340	SUSPENSION ACUOSA QUE CONTIENE NANOPARTICULAS DE GLUCOCORTICOSTEROIDE. (AQUEOUS SUSPENSION AGENT COMPRISING GLUCOCORTICOSTEROID NANOPARTICLES.)	⤷ Sign Up
Russian Federation	2381023	СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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