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Halobetasol propionate; tazarotene - Generic Drug Details
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What are the generic sources for halobetasol propionate; tazarotene and what is the scope of patent protection?
Halobetasol propionate; tazarotene
is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Halobetasol propionate; tazarotene has seventy-four patent family members in twenty-seven countries.
There are nine drug master file entries for halobetasol propionate; tazarotene. One supplier is listed for this compound.
Summary for halobetasol propionate; tazarotene
| International Patents: | 74 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for halobetasol propionate; tazarotene |
| DailyMed Link: | halobetasol propionate; tazarotene at DailyMed |
Recent Clinical Trials for halobetasol propionate; tazarotene
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bausch Health Americas, Inc. | Phase 4 |
| Icahn School of Medicine at Mount Sinai | Phase 4 |
Pharmacology for halobetasol propionate; tazarotene
| Drug Class | Corticosteroid Retinoid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE; TAZAROTENE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DUOBRII | LOTION;TOPICAL | halobetasol propionate; tazarotene | 209354 | 2020-06-11 |
US Patents and Regulatory Information for halobetasol propionate; tazarotene
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 halobetasol propionate; tazarotene
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for halobetasol propionate; tazarotene
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Luxembourg | 92401 | Start Trial |
| Mexico | 2013005764 | Start Trial |
| Lithuania | 3310389 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for halobetasol propionate; tazarotene
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | SPC/GB13/061 | United Kingdom | Start Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
| 1304992 | C300617 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322 |
| 1304992 | 122013000081 | Germany | Start Trial | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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