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Last Updated: November 30, 2022

Clobetasol propionate - Generic Drug Details


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What are the generic drug sources for clobetasol propionate and what is the scope of freedom to operate?

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, Glasshouse Pharms, 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, 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. Forty-eight 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

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SponsorPhase
Fundación Eduardo AnituaPhase 3
Monitor CROPhase 1
TC Erciyes UniversityPhase 1

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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
Cosette CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 074139-001 Aug 3, 1994 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fougera Pharms CLOBETASOL PROPIONATE clobetasol propionate GEL;TOPICAL 075368-001 Feb 15, 2000 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pai Holdings Pharm CLOBETASOL PROPIONATE clobetasol propionate LOTION;TOPICAL 208667-001 Nov 29, 2016 AB RX No 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
Zydus Pharms CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 211074-001 Oct 15, 2018 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Prinston Inc CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 213139-001 Feb 8, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fougera Pharms Inc CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 074392-001 Sep 30, 1996 AB1 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

International Patents for clobetasol propionate

Country Patent Number Title Estimated Expiration
Israel 139940 See Plans and Pricing
Russian Federation 2001101891 See Plans and Pricing
Japan 4972553 See Plans and Pricing
Brazil 9911849 COMPOSIÇÃO ESPUMANTE PARA A LAVAGEM E O TRATAMENTO DOS CABELOS E/OU DO COURO CABELUDO. See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006024095 See Plans and Pricing
China 107872972 包含皮质类固醇的外用组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) See Plans and Pricing
South Africa 200006073 Foaming composition for hair care. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.