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Serving 500+ biopharmaceutical companies globally:

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Generated: June 29, 2017

DrugPatentWatch Database Preview

Details for Patent: 9,359,302

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Which drugs does patent 9,359,302 protect, and when does it expire?


Patent 9,359,302 protects ABILIFY and is included in two NDAs. There have been three Paragraph IV challenges on Abilify.

This patent has one hundred and forty-six patent family members in thirty-one countries.

Summary for Patent: 9,359,302

Title:Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Abstract: The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous aripiprazole crystals is stored for an extended period.
Inventor(s): Bando; Takuji (Tokushima, JP), Aoki; Satoshi (Tokushima, JP), Kawasaki; Junichi (Tokushima, JP), Ishigami; Makoto (Tokushima, JP), Taniguchi; Youichi (Tokushima, JP), Yabuuchi; Tsuyoshi (Tokushima, JP), Fujimoto; Kiyoshi (Tokushima, JP), Nishioka; Yoshihiro (Tokushima, JP), Kobayashi; Noriyuki (Tokushima, JP), Fujimura; Tsutomu (Tokushima, JP), Takahashi; Masanori (Tokushima, JP), Abe; Kaoru (Tokushima, JP), Nakagawa; Tomonori (Tokushima, JP), Shinhama; Koichi (Tokushima, JP), Utsumi; Naoto (Tokushima, JP), Tominaga; Michiaki (Tokushima, JP), Ooi; Yoshihiro (Tokushima, JP), Yamada; Shohei (Tokushima, JP), Tomikawa; Kenji (Tokushima, JP)
Assignee: Otsuka Pharmaceutical Co., Ltd. (Tokyo, JP)
Application Number:14/049,777
Patent Claim Types:
see list of patent claims
Compound; Formulation; Process; Composition; Dosage form; Use; Device;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 2006DISCNNoNo9,359,302► SubscribeYY TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNoNo9,359,302► SubscribeYY TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNYesNo9,359,302► SubscribeYY TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006DISCNYesNo9,359,302► SubscribeYY TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002ABRXYesNo9,359,302► SubscribeYY TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
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Foreign Priority and PCT Information for Patent: 9,359,302

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2001-290645Sep 25, 2001
Japan2001-348276Nov 14, 2001
Canada2379005Mar 27, 2002

Non-Orange Book Patents for Patent: 9,359,302

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
8,580,796Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,703,772Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,399,469Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,993,761Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► 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: 9,359,302

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina033485► Subscribe
Argentina056503► Subscribe
Argentina073111► Subscribe
Argentina077635► Subscribe
Argentina087544► 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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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Accenture
Cerilliant
Covington
Healthtrust
Citi
Fish and Richardson
Julphar
Baxter

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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