TAVABOROLE Drug Patent Profile
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When do Tavaborole patents expire, and what generic alternatives are available?
Tavaborole is a drug marketed by Alembic, Amneal, Chartwell Rx, Cipla, Encube, Lupin Ltd, Padagis Us, Taro, and Zydus Lifesciences. and is included in nine NDAs.
The generic ingredient in TAVABOROLE is tavaborole. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tavaborole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tavaborole
A generic version of TAVABOROLE was approved as tavaborole by ENCUBE on October 13th, 2020.
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Questions you can ask:
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Summary for TAVABOROLE
Recent Clinical Trials for TAVABOROLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
Pharmacology for TAVABOROLE
| Drug Class | Oxaborole Antifungal |
| Mechanism of Action | Protein Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TAVABOROLE
Paragraph IV (Patent) Challenges for TAVABOROLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KERYDIN | Topical Solution | tavaborole | 5% | 204427 | 13 | 2018-07-09 |
US Patents and Regulatory Information for TAVABOROLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212188-001 | Oct 21, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Us | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 211848-001 | Oct 13, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cipla | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212224-001 | Feb 9, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212215-001 | May 7, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212256-001 | Nov 25, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 211963-001 | Feb 3, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212168-001 | Feb 8, 2021 | 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 |
