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Details for Patent: 8,980,931

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Patent 8,980,931 protects LUZU and is included in one NDA.

This patent has two patent family members in one country.

Summary for Patent: 8,980,931

Title:Method of evaluating pharmaceutical preparation containing luliconazole and index substance
Abstract: Disclosed is a method of evaluating stability of a pharmaceutical preparation containing luliconazole. The method includes measuring an amount of production of an SE form of luliconazole represented by following formula (2), an amount of production of a Z form of luliconazole represented by following formula (3) and an amount of production of an amide form of luliconazole represented by following formula (1) after storage under a severe condition or an accelerated condition, and judging that the stability of the pharmaceutical preparation is high if each of the amount of production of the SE form, the amount of production of the Z form and the amount of production of the amide form is not more than 5% by weight with respect to a compounded amount of luliconazole. ##STR00001##
Inventor(s): Masuda; Takaaki (Kanagawa, JP), Yamaguchi; Hiroshi (Tokyo, JP)
Assignee: Pola Pharma Inc. (Tokyo, JP) Nihon Nohyaku Co., Ltd. (Tokyo, JP)
Application Number:14/263,293
Patent Claim Types:
see list of patent claims
Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 15th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Medicis
LUZU
luliconazole
CREAM;TOPICAL204153-001Nov 14, 2013RXYes8,980,931► subscribeY
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Foreign Priority and PCT Information for Patent: 8,980,931

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2013-256584Dec 12, 2013

Non-Orange Book Patents for Patent: 8,980,931

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,085,554Method of evaluating pharmaceutical preparation containing luliconazole and index substance► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,980,931

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2015114210► subscribe
Japan5587488► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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