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Last Updated: April 11, 2021

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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 Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Mylan, Aleor Dermaceuticals, Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Rising, Teligent, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms Inc, Fougera Pharms, Akorn, Encore Dermat, Perrigo Co, Actavis Mid Atlantic, Cadila, Galderma Labs Lp, Novel Labs Inc, Galderma Labs, Macleods Pharms Ltd, Saptalis Pharms, Tolmar, Wockhardt Bio Ag, Apotex, and Paddock Llc, and is included in eighty-nine 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 seventy-eight patent family members in twenty-seven countries.

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

Drug Prices for clobetasol propionate

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Drug Sales Revenue Trends for clobetasol propionate

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Recent Clinical Trials for clobetasol propionate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cairo UniversityPhase 3
Skane University HospitalPhase 2/Phase 3
Malmö UniversityPhase 2/Phase 3

See all clobetasol propionate clinical trials

Pharmacology for clobetasol propionate
Medical Subject Heading (MeSH) Categories for clobetasol propionate
Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
IMPOYZ CREAM;TOPICAL clobetasol propionate 209483 2019-12-06
OLUX E AEROSOL, FOAM;TOPICAL clobetasol propionate 022013 2010-02-25
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
OLUX AEROSOL, FOAM;TOPICAL clobetasol propionate 021142 2005-06-27

US Patents and Regulatory Information for clobetasol propionate

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 SPRAY;TOPICAL 208842-001 Mar 26, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Aleor Dermaceuticals CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 213291-001 Jan 27, 2020 AB1 RX No No   Start Trial   Start Trial   Start Trial
Akorn EMBELINE E clobetasol propionate CREAM;TOPICAL 075325-001 Dec 24, 1998 AB2 RX No No   Start Trial   Start Trial   Start Trial
Fougera Pharms TEMOVATE clobetasol propionate GEL;TOPICAL 020337-001 Apr 29, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Taro CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 074248-001 Jul 12, 1996 AB RX No No   Start Trial   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003 AB 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 clobetasol propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005   Start Trial   Start Trial
Mylan OLUX clobetasol propionate AEROSOL, FOAM;TOPICAL 021142-001 May 26, 2000   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005   Start Trial   Start Trial
Fougera Pharms TEMOVATE clobetasol propionate OINTMENT;TOPICAL 019323-001 Dec 27, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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