Butenafine hydrochloride - Generic Drug Details
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What are the generic drug sources for butenafine hydrochloride and what is the scope of patent protection?
Butenafine hydrochloride
is the generic ingredient in four branded drugs marketed by Taro, Bayer Healthcare Llc, and Norvium Bioscience, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for butenafine hydrochloride. Fourteen suppliers are listed for this compound.
Summary for butenafine hydrochloride
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 4 |
| Patent Applications: | 422 |
| What excipients (inactive ingredients) are in butenafine hydrochloride? | butenafine hydrochloride excipients list |
| DailyMed Link: | butenafine hydrochloride at DailyMed |
Recent Clinical Trials for butenafine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| United Laboratories | Phase 2 |
| Taro Pharmaceuticals USA | Phase 1 |
Pharmacology for butenafine hydrochloride
| Drug Class | Benzylamine Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for butenafine hydrochloride
US Patents and Regulatory Information for butenafine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | BUTENAFINE HYDROCHLORIDE | butenafine hydrochloride | CREAM;TOPICAL | 205181-001 | Nov 16, 2017 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | MENTAX | butenafine hydrochloride | CREAM;TOPICAL | 020524-001 | Oct 18, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | MENTAX-TC | butenafine hydrochloride | CREAM;TOPICAL | 021408-001 | Oct 17, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | LOTRIMIN ULTRA | butenafine hydrochloride | CREAM;TOPICAL | 021307-001 | Dec 7, 2001 | OTC | 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 butenafine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Norvium Bioscience | MENTAX | butenafine hydrochloride | CREAM;TOPICAL | 020524-001 | Oct 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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