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Last Updated: December 7, 2023

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 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, Novel Labs Inc, Taro Pharms, Galderma Labs, Macleods Pharms Ltd, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, and Apotex, and is included in ninety-five 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-six 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

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
Saptalis Pharms CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 211494-001 Oct 2, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Mid Atlantic CLOBETASOL PROPIONATE clobetasol propionate SHAMPOO;TOPICAL 078854-001 Jun 7, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma EMBELINE clobetasol propionate GEL;TOPICAL 076141-001 Apr 12, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms TEMOVATE clobetasol propionate GEL;TOPICAL 020337-001 Apr 29, 1994 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro CLOBETASOL PROPIONATE clobetasol propionate GEL;TOPICAL 075279-001 May 28, 1999 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Mid Atlantic CLOBETASOL PROPIONATE clobetasol propionate LOTION;TOPICAL 078223-001 Dec 4, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd CLOBETASOL PROPIONATE clobetasol propionate LOTION;TOPICAL 209147-001 Sep 22, 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 CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 ⤷  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
Mylan OLUX clobetasol propionate AEROSOL, FOAM;TOPICAL 021142-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms TEMOVATE clobetasol propionate SOLUTION;TOPICAL 019966-001 Feb 22, 1990 ⤷  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 Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003 ⤷  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
European Patent Office 3267978 COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) ⤷  Try a Trial
South Africa 200702702 Microemulsion & sub-micron emulsion process & compositions ⤷  Try a Trial
Japan 4972553 ⤷  Try a Trial
Spain 2861374 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016145407 ⤷  Try a Trial
Canada 2756674 PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS) ⤷  Try a Trial
Poland 1796636 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
McKinsey
Colorcon
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Johnson and Johnson

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