NAFTIFINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Naftifine Hydrochloride, and what generic alternatives are available?
Naftifine Hydrochloride is a drug marketed by Amneal, Taro, and Xiromed. and is included in six NDAs.
The generic ingredient in NAFTIFINE HYDROCHLORIDE is naftifine hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naftifine Hydrochloride
A generic version of NAFTIFINE HYDROCHLORIDE was approved as naftifine hydrochloride by TARO on January 6th, 2016.
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Summary for NAFTIFINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 9 |
| Patent Applications: | 668 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NAFTIFINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in NAFTIFINE HYDROCHLORIDE? | NAFTIFINE HYDROCHLORIDE excipients list |
| DailyMed Link: | NAFTIFINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NAFTIFINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Genzum Life Sciences | Phase 3 |
| GenZum Life Sciences LLC | Phase 3 |
| Semler Research Center Pvt. Ltd. | Phase 3 |
Pharmacology for NAFTIFINE HYDROCHLORIDE
| Drug Class | Allylamine Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for NAFTIFINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NAFTIN | Gel | naftifine hydrochloride | 2% | 204286 | 1 | 2015-02-04 |
US Patents and Regulatory Information for NAFTIFINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 206960-001 | Apr 10, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xiromed | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 210038-001 | Sep 22, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 205975-001 | Sep 8, 2016 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Taro | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 206901-001 | Jan 6, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | GEL;TOPICAL | 208201-001 | Apr 10, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | GEL;TOPICAL | 206165-001 | Mar 20, 2019 | 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 |
