EFINACONAZOLE Drug Patent Profile
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Which patents cover Efinaconazole, and what generic alternatives are available?
Efinaconazole is a drug marketed by Aurobindo Pharma Ltd, Lupin Ltd, Nivagen Pharms Inc, Padagis Us, Teva Pharms Usa, and Zydus. and is included in six NDAs.
The generic ingredient in EFINACONAZOLE is efinaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Efinaconazole
A generic version of EFINACONAZOLE was approved as efinaconazole by TEVA PHARMS USA on December 16th, 2020.
Summary for EFINACONAZOLE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 5 |
| Patent Applications: | 42 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EFINACONAZOLE |
| DailyMed Link: | EFINACONAZOLE at DailyMed |
Recent Clinical Trials for EFINACONAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dong-A ST Co., Ltd. | Phase 4 |
| Western University of Health Sciences | Phase 3 |
| Valeant Pharmaceuticals International, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for EFINACONAZOLE
Paragraph IV (Patent) Challenges for EFINACONAZOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JUBLIA | Topical Solution | efinaconazole | 10% | 203567 | 19 | 2018-06-06 |
US Patents and Regulatory Information for EFINACONAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | EFINACONAZOLE | efinaconazole | SOLUTION;TOPICAL | 212066-001 | Mar 29, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Padagis Us | EFINACONAZOLE | efinaconazole | SOLUTION;TOPICAL | 211851-001 | Dec 16, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | EFINACONAZOLE | efinaconazole | SOLUTION;TOPICAL | 212169-001 | Mar 2, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nivagen Pharms Inc | EFINACONAZOLE | efinaconazole | SOLUTION;TOPICAL | 211969-001 | Jun 21, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
