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Details for Patent: 8,461,187

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Patent 8,461,187 protects DEXILANT SOLUTAB and DEXILANT and is included in two NDAs. There have been two Paragraph IV challenges on Dexilant. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for DEXILANT SOLUTAB has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has eight patent family members in five countries.

Summary for Patent: 8,461,187

Title:Multiple PPI dosage form
Abstract: Herein provided are dosage forms (variously referred to as "formulations") comprising a PPI that is released from the dosage form as a first and a second dose. Each dose of PPI is present in an amount sufficient to raise the plasma levels of the PPI to at least 100 ng/ml.
Inventor(s): Taneja; Rajneesh (Libertyville, IL), Vakilynejad; Majid (Pleasant Prarie, WI)
Assignee: Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:11/629,016
Patent Claim Types:
see list of patent claims
Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 147th 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
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016RXYes8,461,187*PED► subscribeY
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009RXNo8,461,187*PED► subscribeY
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009RXYes8,461,187*PED► subscribeY
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Foreign Priority and PCT Information for Patent: 8,461,187

PCT Information
PCT FiledJune 01, 2005PCT Application Number:PCT/US2005/019028
PCT Publication Date:January 26, 2006PCT Publication Number: WO2006/009602

Non-Orange Book Patents for Patent: 8,461,187

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
9,238,029Multiple PPI dosage form► 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: 8,461,187

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2005264864► subscribe
Canada2570916► subscribe
European Patent Office1768668► 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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