ULTRAVATE Drug Patent Profile
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Which patents cover Ultravate, and what generic alternatives are available?
Ultravate is a drug marketed by Sun Pharm Inds Inc and Sun Pharm Industries and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-two patent family members in eighteen countries.
The generic ingredient in ULTRAVATE 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 Ultravate
A generic version of ULTRAVATE was approved as halobetasol propionate by FOUGERA PHARMS on December 16th, 2004.
Summary for ULTRAVATE
| International Patents: | 22 |
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 8 |
| Patent Applications: | 5,226 |
| Drug Prices: | Drug price information for ULTRAVATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ULTRAVATE |
| What excipients (inactive ingredients) are in ULTRAVATE? | ULTRAVATE excipients list |
| DailyMed Link: | ULTRAVATE at DailyMed |
Recent Clinical Trials for ULTRAVATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Valeant Pharmaceuticals International, Inc. | Phase 2 |
| Bausch Health Americas, Inc. | Phase 2 |
| Valeant Pharmaceuticals International, Inc. | Phase 1 |
Pharmacology for ULTRAVATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for ULTRAVATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ULTRAVATE | Lotion | halobetasol propionate | 0.05% | 208183 | 1 | 2018-01-24 |
US Patents and Regulatory Information for ULTRAVATE
ULTRAVATE is protected by one US patents.
Patents protecting ULTRAVATE
Topical steroid composition and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | ULTRAVATE | halobetasol propionate | CREAM;TOPICAL | 019967-001 | Dec 27, 1990 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Industries | ULTRAVATE | halobetasol propionate | LOTION;TOPICAL | 208183-001 | Nov 6, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sun Pharm Inds Inc | ULTRAVATE | halobetasol propionate | OINTMENT;TOPICAL | 019968-001 | Dec 17, 1990 | DISCN | Yes | 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 ULTRAVATE
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ULTRAVATE
See the table below for patents covering ULTRAVATE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Belgium | 859120 | ⤷ Try a Trial | |
| Australia | 2914877 | ⤷ Try a Trial | |
| Canada | 2888853 | PROCEDE ET COMPOSITION DE STEROIDE TOPIQUE (TOPICAL STEROID COMPOSITION AND METHOD) | ⤷ Try a Trial |
| Austria | A81079 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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