BUTOCONAZOLE NITRATE - Generic Drug Details
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What are the generic drug sources for butoconazole nitrate and what is the scope of patent protection?
Butoconazole nitrate
is the generic ingredient in four branded drugs marketed by Padagis Us, Roche Palo, Bayer, and Padagis Israel, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for butoconazole nitrate. One supplier is listed for this compound.
Summary for BUTOCONAZOLE NITRATE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,435 |
| What excipients (inactive ingredients) are in BUTOCONAZOLE NITRATE? | BUTOCONAZOLE NITRATE excipients list |
| DailyMed Link: | BUTOCONAZOLE NITRATE at DailyMed |
Recent Clinical Trials for BUTOCONAZOLE NITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EMS | Phase 2 |
| Perrigo Company | N/A |
| Padagis LLC | N/A |
Pharmacology for BUTOCONAZOLE NITRATE
| Drug Class | Azole Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for BUTOCONAZOLE NITRATE
US Patents and Regulatory Information for BUTOCONAZOLE NITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roche Palo | FEMSTAT | butoconazole nitrate | CREAM;VAGINAL | 019215-001 | Nov 25, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer | FEMSTAT 3 | butoconazole nitrate | CREAM;VAGINAL | 020421-001 | Dec 21, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Padagis Israel | GYNAZOLE-1 | butoconazole nitrate | CREAM;VAGINAL | 200923-001 | May 18, 2012 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Padagis Us | BUTOCONAZOLE NITRATE | butoconazole nitrate | CREAM;VAGINAL | 019881-001 | Feb 7, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche Palo | FEMSTAT | butoconazole nitrate | SUPPOSITORY;VAGINAL | 019359-001 | Nov 25, 1985 | DISCN | 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 |
Expired US Patents for BUTOCONAZOLE NITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Padagis Us | BUTOCONAZOLE NITRATE | butoconazole nitrate | CREAM;VAGINAL | 019881-001 | Feb 7, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Padagis Us | BUTOCONAZOLE NITRATE | butoconazole nitrate | CREAM;VAGINAL | 019881-001 | Feb 7, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Roche Palo | FEMSTAT | butoconazole nitrate | CREAM;VAGINAL | 019215-001 | Nov 25, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Roche Palo | FEMSTAT | butoconazole nitrate | SUPPOSITORY;VAGINAL | 019359-001 | Nov 25, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer | FEMSTAT 3 | butoconazole nitrate | CREAM;VAGINAL | 020421-001 | Dec 21, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Padagis Us | BUTOCONAZOLE NITRATE | butoconazole nitrate | CREAM;VAGINAL | 019881-001 | Feb 7, 1997 | ⤷ 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.
ISSN: 2162-2639
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