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FABIOR Drug Profile
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Which patents cover Fabior, and when can generic versions of Fabior launch?
Fabior is a drug marketed by Mayne Pharma and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-four patent family members in eighteen countries.
The generic ingredient in FABIOR is tazarotene. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
US ANDA Litigation and Generic Entry Outlook for Fabior
A generic version of FABIOR was approved as tazarotene by TARO PHARMS on April 3rd, 2017.
Summary for FABIOR
| International Patents: | 24 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 102 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,439 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FABIOR |
| DailyMed Link: | FABIOR at DailyMed |
Recent Clinical Trials for FABIOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Actavis Inc. | Phase 3 |
Pharmacology for FABIOR
| Drug Class | Retinoid |
US Patents and Regulatory Information for FABIOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | FABIOR | tazarotene | AEROSOL, FOAM;TOPICAL | 202428-001 | May 11, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mayne Pharma | FABIOR | tazarotene | AEROSOL, FOAM;TOPICAL | 202428-001 | May 11, 2012 | 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 |
International Patents for FABIOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6182191 | Start Trial |
| Poland | 2400951 | Start Trial |
| Canada | 2753497 | Start Trial |
| Japan | 6130992 | Start Trial |
| Israel | 214520 | Start Trial |
| Denmark | 2400951 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FABIOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0284288 | SPC/GB98/002 | United Kingdom | Start Trial | PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730 |
| 0284288 | 12/1998 | Austria | Start Trial | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203 |
| 0031058 | 98C0008 | Belgium | Start Trial | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
