NAFTIFINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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 Amneal, Taro, Xiromed, and Sebela Ireland Ltd, and is included in nine NDAs. There are six 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 seven drug master file entries for naftifine hydrochloride. Three suppliers are listed for this compound.
Summary for NAFTIFINE HYDROCHLORIDE
| International Patents: | 3 |
| US Patents: | 6 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 9 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 9 |
| Patent Applications: | 908 |
| 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 |
|---|---|
| Semler Research Center Pvt. Ltd. | Phase 3 |
| Genzum Life Sciences | Phase 3 |
| GenZum Life Sciences LLC | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amneal | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | GEL;TOPICAL | 206165-001 | Mar 20, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 206960-001 | Apr 10, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286-001 | Jun 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 019356-001 | Jun 18, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 019356-001 | Jun 18, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAFTIFINE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014212201 | Topical compositions and methods for making and using same | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014121048 | ⤷ Sign Up | |
| Canada | 2899725 | COMPOSITIONS TOPIQUES ET PROCEDES DE PREPARATION ET D'UTILISATION CORRESPONDANTS (TOPICAL COMPOSITIONS AND METHODS FOR MAKING AND USING SAME) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >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.
ISSN: 2162-2639
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