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Last Updated: February 26, 2024

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 Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Mylan, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Fougera Pharms, Hikma, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Cadila, Epic Pharma Llc, Galderma Labs Lp, Macleods Pharms Ltd, Novel Labs Inc, Galderma Labs, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, and Apotex, and is included in ninety-six NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has forty-eight patent family members in twenty-two countries.

There are eleven drug master file entries for clobetasol propionate. Forty-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
GEN İlaç ve Sağlık Ürünleri A.Ş.Phase 2
Monitor CROPhase 2
Combined Military Hospital AbbottabadPhase 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
Macleods Pharms Ltd CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 209361-001 Oct 25, 2017 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal CLOBETASOL PROPIONATE clobetasol propionate SHAMPOO;TOPICAL 214895-001 Jun 14, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 075057-001 Aug 12, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 210190-001 Apr 18, 2018 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma CLOBETASOL PROPIONATE clobetasol propionate SHAMPOO;TOPICAL 209871-001 Oct 27, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms TEMOVATE clobetasol propionate OINTMENT;TOPICAL 019323-001 Dec 27, 1985 ⤷  Try a Trial ⤷  Try a Trial
Mylan OLUX clobetasol propionate AEROSOL, FOAM;TOPICAL 021142-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for clobetasol propionate

Country Patent Number Title Estimated Expiration
Japan 2008511550 ⤷  Try a Trial
Colombia 2017010091 Composiciones tópicas que comprenden un corticosteroide ⤷  Try a Trial
Poland 1796636 ⤷  Try a Trial
China 107872972 包含皮质类固醇的外用组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) ⤷  Try a Trial
Eurasian Patent Organization 201791921 КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИД ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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