HALOBETASOL PROPIONATE Drug Patent Profile
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When do Halobetasol Propionate patents expire, and what generic alternatives are available?
Halobetasol Propionate is a drug marketed by Padagis Israel, Cosette, Fougera Pharms, Taro, Encube, and Quagen. and is included in thirteen NDAs.
The generic ingredient in HALOBETASOL PROPIONATE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Halobetasol Propionate
A generic version of HALOBETASOL PROPIONATE was approved as halobetasol propionate by FOUGERA PHARMS on December 16th, 2004.
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Questions you can ask:
- What is the 5 year forecast for HALOBETASOL PROPIONATE?
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- What is Average Wholesale Price for HALOBETASOL PROPIONATE?
Summary for HALOBETASOL PROPIONATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 21 |
| Patent Applications: | 4,752 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Dermatology Consulting Services, PLLC | Phase 4 |
| Icahn School of Medicine at Mount Sinai | Phase 3 |
| Citius Pharmaceuticals, Inc. | Phase 2 |
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
HALOBETASOL PROPIONATE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting HALOBETASOL PROPIONATE
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | HALOBETASOL PROPIONATE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 215266-001 | Aug 11, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | HALOBETASOL PROPIONATE | halobetasol propionate | OINTMENT;TOPICAL | 077109-001 | Jun 14, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Israel | HALOBETASOL PROPIONATE | halobetasol propionate | CREAM;TOPICAL | 077123-001 | Dec 16, 2004 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
