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Last Updated: July 2, 2022

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 Aleor Dermaceuticals, Glenmark Pharms Ltd, Ingenus Pharms Llc, Padagis Israel, Taro, Mylan, Amneal, Aurobindo Pharma Usa, Cosette Pharms, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Fougera Pharms, Akorn, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Cadila, Galderma Labs Lp, Novel Labs Inc, Taro Pharms, Galderma Labs, Macleods Pharms Ltd, Prinston Inc, Saptalis Pharms, Solaris Pharma Corp, Tolmar, Wockhardt Bio Ag, and Apotex, and is included in ninety-five 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 eighty patent family members in twenty-seven countries.

There are eleven 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
Fundación Eduardo AnituaPhase 3
University of South AlabamaPhase 2/Phase 3
Patty Brisben Foundation For Women's Sexual HealthPhase 4

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 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Encube CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 212982-001 Aug 28, 2020 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn CORMAX clobetasol propionate CREAM;TOPICAL 074220-001 May 16, 1997 AB1 RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn EMBELINE E clobetasol propionate CREAM;TOPICAL 075325-001 Dec 24, 1998 AB2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fougera Pharms TEMOVATE E clobetasol propionate CREAM;TOPICAL 020340-001 Jun 17, 1994 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fougera Pharms TEMOVATE clobetasol propionate SOLUTION;TOPICAL 019966-001 Feb 22, 1990 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 See Plans and Pricing See Plans and Pricing
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 See Plans and Pricing See Plans and Pricing
Fougera Pharms TEMOVATE clobetasol propionate CREAM;TOPICAL 019322-001 Dec 27, 1985 See Plans and Pricing See Plans and Pricing
Mylan OLUX clobetasol propionate AEROSOL, FOAM;TOPICAL 021142-001 May 26, 2000 See Plans and Pricing See Plans and Pricing
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for clobetasol propionate

Country Patent Number Title Estimated Expiration
France 2761600 COMPOSITION MOUSSANTE POUR LE LAVAGE ET LE TRAITEMENT DES CHEVEUX ET/OU DU CUIR CHEVELU A BASE D'UN PRINCIPE ACTIF, D'UN TENSIOACTIF ANIONIQUE, D'UN TENSIOACTIF AMPHOTERE ET D'UN AGENT PROPENETRANT See Plans and Pricing
New Zealand 735341 Topical compositions comprising a corticosteroid See Plans and Pricing
China 1306413 See Plans and Pricing
Germany 69928253 See Plans and Pricing
South Korea 101243526 See Plans and Pricing
South Korea 20200051854 코르티코스테로이드를 포함하는 국소용 조성물 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
McKinsey
Colorcon
Express Scripts
Johnson and Johnson

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.