HALOBETASOL PROPIONATE - Generic Drug Details
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What are the generic drug sources for halobetasol propionate and what is the scope of patent protection?
Halobetasol propionate
is the generic ingredient in five branded drugs marketed by Mayne Pharma, Cosette, Fougera Pharms, Padagis Israel, Taro, Sun Pharm Inds Inc, Bausch, Sun Pharm Industries, Pai Holdings Pharm, and Quagen, and is included in eighteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Halobetasol propionate has seventy patent family members in twenty-four countries.
There are nine drug master file entries for halobetasol propionate. Nine suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for HALOBETASOL PROPIONATE
International Patents: | 70 |
US Patents: | 7 |
Tradenames: | 5 |
Applicants: | 10 |
NDAs: | 18 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 20 |
Patent Applications: | 6,868 |
Drug Prices: | Drug price trends for HALOBETASOL PROPIONATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HALOBETASOL PROPIONATE |
What excipients (inactive ingredients) are in HALOBETASOL PROPIONATE? | HALOBETASOL PROPIONATE excipients list |
DailyMed Link: | HALOBETASOL PROPIONATE at DailyMed |
Recent Clinical Trials for HALOBETASOL PROPIONATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Icahn School of Medicine at Mount Sinai | Phase 3 |
Citius Pharmaceuticals, Inc. | Phase 2 |
Taro Pharmaceuticals USA | Early Phase 1 |
Generic filers with tentative approvals for HALOBETASOL PROPIONATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | UNKNOWN | UNKNOWN |
⤷ Try a Trial | ⤷ Try a Trial | 0.05% | FOAM;TOPICAL |
⤷ Try a Trial | ⤷ Try a Trial | 0.01%;0.045% | LOTION;TOPICAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for HALOBETASOL PROPIONATE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LEXETTE | Topical Foam | halobetasol propionate | 0.05% | 210566 | 1 | 2021-01-28 |
BRYHALI | Lotion | halobetasol propionate | 0.01% | 209355 | 1 | 2019-05-15 |
ULTRAVATE | Lotion | halobetasol propionate | 0.05% | 208183 | 1 | 2018-01-24 |
US Patents and Regulatory Information for HALOBETASOL PROPIONATE
Expired US Patents for HALOBETASOL PROPIONATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sun Pharm Inds Inc | ULTRAVATE | halobetasol propionate | CREAM;TOPICAL | 019967-001 | Dec 27, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ULTRAVATE | halobetasol propionate | OINTMENT;TOPICAL | 019968-001 | Dec 17, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | BRYHALI | halobetasol propionate | LOTION;TOPICAL | 209355-001 | Nov 6, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HALOBETASOL PROPIONATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 201590730 | СПОСОБ И СТЕРОИДНАЯ КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ | ⤷ Try a Trial |
China | 108601726 | 含有皮质类固醇的泡沫组合物及其制备方法 (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF) | ⤷ Try a Trial |
South Africa | 201502692 | TOPICAL STEROID COMPOSITION AND METHOD | ⤷ Try a Trial |
New Zealand | 706918 | Topical steroid composition and method | ⤷ Try a Trial |
Canada | 2817524 | FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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