NAFTIN Drug Patent Profile
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Which patents cover Naftin, and what generic alternatives are available?
Naftin is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has three patent family members in three countries.
The generic ingredient in NAFTIN 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 Naftin
A generic version of NAFTIN was approved as naftifine hydrochloride by TARO on January 6th, 2016.
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Summary for NAFTIN
| International Patents: | 3 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 8 |
| Patent Applications: | 668 |
| Drug Prices: | Drug price information for NAFTIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NAFTIN |
| What excipients (inactive ingredients) are in NAFTIN? | NAFTIN excipients list |
| DailyMed Link: | NAFTIN at DailyMed |
Recent Clinical Trials for NAFTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Therapeutics, Inc. | Phase 1 |
| GenZum Life Sciences LLC | Phase 3 |
| Semler Research Center Pvt. Ltd. | Phase 3 |
Pharmacology for NAFTIN
| Drug Class | Allylamine Antifungal |
Paragraph IV (Patent) Challenges for NAFTIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NAFTIN | Gel | naftifine hydrochloride | 2% | 204286 | 1 | 2015-02-04 |
US Patents and Regulatory Information for NAFTIN
NAFTIN is protected by six US patents.
Patents protecting NAFTIN
Topical compositions and methods for making and using same
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Topical compositions and methods for making and using same
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Topical compositions and methods for making and using same
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Topical compositions and methods for making and using same
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Topical compositions and methods for making and using same
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Topical compositions and methods for making and using same
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Patented Use: TREATMENT OF FUNGAL INFECTIONS
| 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 | CREAM;TOPICAL | 019599-001 | Feb 29, 1988 | DISCN | Yes | 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 | ⤷ 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 NAFTIN
| 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 NAFTIN
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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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