Luliconazole - Generic Drug Details
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What are the generic sources for luliconazole and what is the scope of patent protection?
Luliconazole
is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Luliconazole has thirty-one patent family members in seven countries.
There are six drug master file entries for luliconazole. Two suppliers are listed for this compound.
Summary for luliconazole
International Patents: | 31 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 8 |
Patent Applications: | 45 |
Drug Prices: | Drug price trends for luliconazole |
What excipients (inactive ingredients) are in luliconazole? | luliconazole excipients list |
DailyMed Link: | luliconazole at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for luliconazole
Generic Entry Date for luliconazole*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for luliconazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
SATO Pharmaceutical Co., Ltd. | Phase 1 |
Valeant Pharmaceuticals | Phase 4 |
Bausch Health Americas, Inc. | Phase 4 |
Pharmacology for luliconazole
Drug Class | Azole Antifungal |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors |
US Patents and Regulatory Information for luliconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bausch | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bausch | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 luliconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for luliconazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2964641 | FORME CRISTALLINE À HABITUDE CRISTALLINE SPECIFIQUE ET COMPOSITION PHARMACEUTIQUE CONTENANT CETTE FORME CRISTALLINE COMME INGRÉDIENT ACTIF (CRYSTALLINE FORM HAVING SPECIFIC CRYSTAL HABIT AND PHARMACEUTICAL COMPOSITION CONTAINING THIS CRYSTALLINE FORM AS ACTIVE INGREDIENT) | ⤷ Try a Trial |
Japan | 2015091890 | 結晶及び該結晶を含有してなる医薬製剤 (CRYSTAL AND PHARMACEUTICAL FORMULATION COMPRISING THE CRYSTAL) | ⤷ Try a Trial |
Japan | 2015027984 | 結晶及び該結晶を含有してなる医薬製剤 (CRYSTAL AND PHARMACEUTICAL PREPARATION CONTAINING THE CRYSTAL) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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