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Last Updated: August 6, 2020

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CLOBEX Drug Profile

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Which patents cover Clobex, and what generic alternatives are available?

Clobex is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has thirty-two patent family members in twenty-one countries.

The generic ingredient in CLOBEX is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Drug patent expirations by year for CLOBEX
Drug Prices for CLOBEX

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Drug Sales Revenue Trends for CLOBEX

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Recent Clinical Trials for CLOBEX

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SponsorPhase
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)Phase 1
University of California, San FranciscoPhase 4
Galderma LaboratoriesPhase 4

See all CLOBEX clinical trials

Pharmacology for CLOBEX
Paragraph IV (Patent) Challenges for CLOBEX
Tradename Dosage Ingredient NDA Submissiondate
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

US Patents and Regulatory Information for CLOBEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 AT 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 CLOBEX

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   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Harvard Business School
Colorcon

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