ECONAZOLE NITRATE - Generic Drug Details
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What are the generic sources for econazole nitrate and what is the scope of freedom to operate?
Econazole nitrate
is the generic ingredient in three branded drugs marketed by Resilia Pharms, Aurobindo Pharma Usa, Chartwell Rx, Encube, Padagis Israel, Taro, and Alvogen, and is included in seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Econazole nitrate has two patent family members in two countries.
There are nine drug master file entries for econazole nitrate. Six suppliers are listed for this compound.
Summary for ECONAZOLE NITRATE
| International Patents: | 2 |
| US Patents: | 1 |
| Tradenames: | 3 |
| Applicants: | 7 |
| NDAs: | 7 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 7 |
| Patent Applications: | 2,655 |
| Drug Prices: | Drug price trends for ECONAZOLE NITRATE |
| What excipients (inactive ingredients) are in ECONAZOLE NITRATE? | ECONAZOLE NITRATE excipients list |
| DailyMed Link: | ECONAZOLE NITRATE at DailyMed |
Recent Clinical Trials for ECONAZOLE NITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| DPT Laboratories, Ltd. | Phase 3 |
| Mylan Inc. | Phase 3 |
| Aziende Chimiche Riunite Angelini Francesco S.p.A | Phase 1 |
Pharmacology for ECONAZOLE NITRATE
| Drug Class | Azole Antifungal |
Medical Subject Heading (MeSH) Categories for ECONAZOLE NITRATE
Anatomical Therapeutic Chemical (ATC) Classes for ECONAZOLE NITRATE
US Patents and Regulatory Information for ECONAZOLE NITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alvogen | SPECTAZOLE | econazole nitrate | CREAM;TOPICAL | 018751-001 | Dec 23, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Padagis Israel | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076479-001 | Jun 23, 2004 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076005-001 | Nov 26, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Usa | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 210364-001 | Apr 18, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Encube | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076574-001 | Dec 17, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076075-001 | Nov 26, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Resilia Pharms | ECOZA | econazole nitrate | AEROSOL, FOAM;TOPICAL | 205175-001 | Oct 24, 2013 | 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 ECONAZOLE NITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Resilia Pharms | ECOZA | econazole nitrate | AEROSOL, FOAM;TOPICAL | 205175-001 | Oct 24, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Alvogen | SPECTAZOLE | econazole nitrate | CREAM;TOPICAL | 018751-001 | Dec 23, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Alvogen | SPECTAZOLE | econazole nitrate | CREAM;TOPICAL | 018751-001 | Dec 23, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ECONAZOLE NITRATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012057894 | ⤷ Sign Up | |
| European Patent Office | 2672968 | COMPOSITION D'ECONAZOLE ET MÉTHODES DE TRAITEMENT AU MOYEN DE CETTE COMPOSITION (ECONAZOLE COMPOSITION AND METHODS OF TREATMENT THEREWITH) | ⤷ 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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