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 Pharms, 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 suppliers are listed for this compound.
Summary for clobetasol propionate
International Patents: | 80 |
US Patents: | 7 |
Tradenames: | 12 |
Applicants: | 37 |
NDAs: | 95 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 50 |
Raw Ingredient (Bulk) Api Vendors: | 71 |
Clinical Trials: | 61 |
Patent Applications: | 6,672 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for clobetasol propionate |
Drug Sales Revenues: | Drug sales revenues for clobetasol propionate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for clobetasol propionate |
What excipients (inactive ingredients) are in clobetasol propionate? | clobetasol propionate excipients list |
DailyMed Link: | clobetasol propionate at DailyMed |
Recent Clinical Trials for clobetasol propionate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fundación Eduardo Anitua | Phase 3 |
University of South Alabama | Phase 2/Phase 3 |
Patty Brisben Foundation For Women's Sexual Health | Phase 4 |
Pharmacology for clobetasol propionate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for clobetasol propionate
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |
Fougera Pharms | TEMOVATE | clobetasol propionate | CREAM;TOPICAL | 019322-001 | Dec 27, 1985 | See Plans and Pricing | See Plans and Pricing |
Mylan | OLUX | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 021142-001 | May 26, 2000 | See Plans and Pricing | See Plans and Pricing |
Mylan | OLUX E | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 022013-001 | Jan 12, 2007 | 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 |
---|---|---|---|
France | 2761600 | COMPOSITION MOUSSANTE POUR LE LAVAGE ET LE TRAITEMENT DES CHEVEUX ET/OU DU CUIR CHEVELU A BASE D'UN PRINCIPE ACTIF, D'UN TENSIOACTIF ANIONIQUE, D'UN TENSIOACTIF AMPHOTERE ET D'UN AGENT PROPENETRANT | See Plans and Pricing |
New Zealand | 735341 | Topical compositions comprising a corticosteroid | See Plans and Pricing |
China | 1306413 | See Plans and Pricing | |
Germany | 69928253 | See Plans and Pricing | |
South Korea | 101243526 | See Plans and Pricing | |
South Korea | 20200051854 | 코르티코스테로이드를 포함하는 국소용 조성물 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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