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Last Updated: March 19, 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, Epic Pharma Llc, Zydus Lifesciences, 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
Monitor CROPhase 2
GEN İlaç ve Sağlık Ürünleri A.Ş.Phase 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
Actavis Mid Atlantic CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 074128-001 Aug 3, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Quagen CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 211240-001 Feb 17, 2022 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt Bio Ag CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 075205-001 Nov 13, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CLOBETASOL PROPIONATE clobetasol propionate SPRAY;TOPICAL 090898-001 Jun 16, 2011 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 212881-001 Oct 21, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075430-001 May 26, 1999 AB2 RX No Yes ⤷  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
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 Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms TEMOVATE clobetasol propionate CREAM;TOPICAL 019322-001 Dec 27, 1985 ⤷  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
European Patent Office 3267978 COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) ⤷  Try a Trial
Japan 2021008505 コルチコステロイドを含む局所用組成物 (TOPICAL COMPOSITIONS COMPRISING CORTICOSTEROID) ⤷  Try a Trial
Ukraine 121232 КОМПОЗИЦІЇ ДЛЯ МІСЦЕВОГО ЗАСТОСУВАННЯ, ЩО МІСТЯТЬ КОРТИКОСТЕРОЇД (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) ⤷  Try a Trial
Japan 2008511550 ⤷  Try a Trial
Spain 2861374 ⤷  Try a Trial
Brazil 112017019352 composições tópicas comprimidas a corticosteróide aplicações relacionadas ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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