TAZAROTENE - Generic Drug Details
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What are the generic drug sources for tazarotene and what is the scope of freedom to operate?
Tazarotene
is the generic ingredient in five branded drugs marketed by Mayne Pharma, Allergan, Cosette, Fougera Pharms Inc, Taro, Padagis Israel, Solaris Pharma Corp, and Bausch, and is included in eleven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tazarotene has fifty-one patent family members in twenty-four countries.
There are eight drug master file entries for tazarotene. Eleven suppliers are listed for this compound.
Summary for TAZAROTENE
International Patents: | 51 |
US Patents: | 5 |
Tradenames: | 5 |
Applicants: | 8 |
NDAs: | 11 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 129 |
Clinical Trials: | 52 |
Patent Applications: | 6,984 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for TAZAROTENE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAZAROTENE |
What excipients (inactive ingredients) are in TAZAROTENE? | TAZAROTENE excipients list |
DailyMed Link: | TAZAROTENE at DailyMed |
Recent Clinical Trials for TAZAROTENE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ortho Dermatologics | Phase 4 |
Dermatology Consulting Services, PLLC | Phase 4 |
Zagazig University | Phase 2 |
Pharmacology for TAZAROTENE
Drug Class | Retinoid |
Paragraph IV (Patent) Challenges for TAZAROTENE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ARAZLO | Topical Lotion | tazarotene | 0.045% | 211882 | 1 | 2022-05-12 |
US Patents and Regulatory Information for TAZAROTENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Israel | TAZAROTENE | tazarotene | GEL;TOPICAL | 213079-001 | Apr 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Allergan | TAZORAC | tazarotene | CREAM;TOPICAL | 021184-002 | Sep 29, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | TAZAROTENE | tazarotene | CREAM;TOPICAL | 208662-001 | Dec 22, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Solaris Pharma Corp | TAZAROTENE | tazarotene | GEL;TOPICAL | 213644-001 | Mar 20, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Solaris Pharma Corp | TAZAROTENE | tazarotene | GEL;TOPICAL | 213644-002 | Mar 20, 2023 | 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 |
Expired US Patents for TAZAROTENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | TAZORAC | tazarotene | GEL;TOPICAL | 020600-002 | Jun 13, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | TAZORAC | tazarotene | CREAM;TOPICAL | 021184-002 | Sep 29, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | AVAGE | tazarotene | CREAM;TOPICAL | 021184-003 | Sep 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | TAZORAC | tazarotene | GEL;TOPICAL | 020600-001 | Jun 13, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | TAZORAC | tazarotene | GEL;TOPICAL | 020600-001 | Jun 13, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | TAZORAC | tazarotene | GEL;TOPICAL | 020600-001 | Jun 13, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TAZAROTENE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2016205001 | ⤷ Sign Up | |
Eurasian Patent Organization | 201171079 | ПЕНООБРАЗУЮЩАЯ КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ | ⤷ Sign Up |
Serbia | 60672 | TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS) | ⤷ Sign Up |
Canada | 2753497 | COMPOSITION DE MOUSSE A USAGE TOPIQUE (TOPICAL FOAM COMPOSITION) | ⤷ Sign Up |
Japan | 2012518662 | ⤷ Sign Up | |
Mexico | 2017015990 | COMPOSICIONES TOPICAS QUE COMPRENDEN UN CORTICOSTEROIDE Y UN RETINOIDE PARA TRATAR PSORIASIS. (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAZAROTENE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0031058 | 98C0008 | Belgium | ⤷ Sign Up | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203 |
0284288 | 12/1998 | Austria | ⤷ Sign Up | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203 |
0284288 | SPC/GB98/002 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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