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Last Updated: June 27, 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, 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-one 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
Society of Gynecologic SurgeonsPhase 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
Glenmark Pharms Ltd CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM;TOPICAL 210809-001 Feb 15, 2019 AB1 RX No 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
Taro Pharms CLOBETASOL PROPIONATE clobetasol propionate SHAMPOO;TOPICAL 214867-001 Mar 25, 2021 AB RX No 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CLOBETASOL PROPIONATE

Country Patent Number Title Estimated Expiration
European Patent Office 2473161 COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID) See Plans and Pricing
Japan 4972553 See Plans and Pricing
Eurasian Patent Organization 201791921 КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИД See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
McKesson
Mallinckrodt
Harvard Business School
Baxter

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.