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Naftifine hydrochloride - Generic Drug Details
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What are the generic sources for naftifine hydrochloride and what is the scope of freedom to operate?
Naftifine hydrochloride
is the generic ingredient in two branded drugs marketed by Taro Pharms, Tolmar, Sebela Ireland Ltd, and Taro, and is included in eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Naftifine hydrochloride has three patent family members in three countries.
There are eight drug master file entries for naftifine hydrochloride. Four suppliers are listed for this compound.
Summary for naftifine hydrochloride
| International Patents: | 3 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 8 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 9 |
| Patent Applications: | 524 |
| DailyMed Link: | naftifine hydrochloride at DailyMed |
Recent Clinical Trials for naftifine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Semler Research Center Pvt. Ltd. | Phase 3 |
| GenZum Life Sciences LLC | Phase 3 |
| Merz Pharmaceuticals, LLC | Phase 4 |
Pharmacology for naftifine hydrochloride
| Drug Class | Allylamine Antifungal |
Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NAFTIN | GEL;TOPICAL | naftifine hydrochloride | 204286 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | GEL;TOPICAL | 208201-001 | Apr 10, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Taro Pharms | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 205975-001 | Sep 8, 2016 | RX | No | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 019356-001 | Jun 18, 1990 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | CREAM;TOPICAL | 019599-001 | Feb 29, 1988 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 naftifine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | CREAM;TOPICAL | 019599-001 | Feb 29, 1988 | Start Trial | Start Trial |
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 019356-001 | Jun 18, 1990 | Start Trial | Start Trial |
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 019356-001 | Jun 18, 1990 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for naftifine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2014212201 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2014121048 | Start Trial |
| Canada | 2899725 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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