TAZAROTENE Drug Patent Profile
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When do Tazarotene patents expire, and when can generic versions of Tazarotene launch?
Tazarotene is a drug marketed by Cosette, Fougera Pharms Inc, Padagis Israel, Taro, and Solaris Pharma Corp. and is included in eight NDAs.
The generic ingredient in TAZAROTENE is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tazarotene
A generic version of TAZAROTENE was approved as tazarotene by TARO on April 3rd, 2017.
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Summary for TAZAROTENE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 53 |
| Patent Applications: | 5,255 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Dermatology Consulting Services, PLLC | Phase 4 |
| Ortho Dermatologics | Phase 4 |
| Zagazig University | Phase 2 |
Pharmacology for TAZAROTENE
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for TAZAROTENE
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
TAZAROTENE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting TAZAROTENE
COMPETITIVE GENERIC THERAPY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | TAZAROTENE | tazarotene | CREAM;TOPICAL | 208662-001 | Dec 22, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Israel | TAZAROTENE | tazarotene | GEL;TOPICAL | 213079-001 | Apr 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | TAZAROTENE | tazarotene | CREAM;TOPICAL | 208258-001 | Apr 3, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Israel | TAZAROTENE | tazarotene | GEL;TOPICAL | 213079-002 | Apr 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fougera Pharms Inc | TAZAROTENE | tazarotene | CREAM;TOPICAL | 211175-001 | Jan 28, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Padagis Israel | TAZAROTENE | tazarotene | CREAM;TOPICAL | 217075-001 | Jul 15, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | TAZAROTENE | tazarotene | GEL;TOPICAL | 214136-001 | Sep 13, 2022 | 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 |
