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Details for Patent: 8,815,801

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Patent 8,815,801 protects LUPRON DEPOT and is included in one NDA.

This patent has fifty-nine patent family members in thirty-three countries.

Summary for Patent: 8,815,801

Title:Controlled release composition and method of producing the same
Abstract: A controlled release composition containing a physiologically active substance in high content, suppressing the initial excess release, and achieving a stable release speed over a long period of time is provided. A controlled release composition comprising (1) a physiologically active substance or salt thereof in an amount of about 14% (w/w) to about 24% (w/w) based on the total composition weight, (2) hydroxynaphthoic acid selected from the group consisting of 3-hydroxy-2-naphthoic acid and 1-hydroxy-2-naphthoic acid or salt thereof, and (3) a lactic acid polymer or salt thereof having a weight-average molecular weight of 15000 to 50000 in which the content of polymers having molecular weights of 5000 or less is about 5% by weight or less, wherein the molar ratio of said hydroxynaphthoic acid or salt thereof to said physiologically active substance or salt thereof is from 3:4 to 4:3.
Inventor(s): Yamamoto; Kazumichi (Kyoto, JP), Yamada; Akiko (Kyoto, JP), Hata; Yoshio (Hokkaido, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:13/548,463
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-003Jun 17, 2011RXNo8,815,801► subscribeY
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Foreign Priority and PCT Information for Patent: 8,815,801

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2001-199484Jun 29, 2001
Japan2001-340993Nov 6, 2001

Non-Orange Book Patents for Patent: 8,815,801

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
8,246,987Controlled release composition and method of producing the same► subscribe
7,429,559Controlled release composition and method of producing the same► subscribe
8,067,030Controlled release composition and method of producing the same► 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: 8,815,801

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Israel159059► subscribe
European Patent Office1949936► subscribe
Spain2263788► 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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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 verifification 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.

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