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: | 2,573 |
Formulation / Manufacturing: | see details |
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 |
Cross Research S.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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Israel | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076479-001 | Jun 23, 2004 | AB | RX | No | Yes | ⤷ 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 | ||||
Chartwell Rx | ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076075-001 | Nov 26, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alvogen | SPECTAZOLE | econazole nitrate | CREAM;TOPICAL | 018751-001 | Dec 23, 1982 | DISCN | Yes | 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 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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