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Dexlansoprazole - Generic Drug Details

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Dexlansoprazole is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and is included in two NDAs. There are twenty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fourteen patent family members in thirty-nine countries.

There are fifteen drug master file entries for dexlansoprazole. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: dexlansoprazole

Tradenames:2
Patents:21
Applicants:1
NDAs:2
Drug Master File Entries: see list15
Suppliers / Packaging: see list3
Drug Prices:see low prices

Pharmacology for Ingredient: dexlansoprazole

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Tentative approvals for DEXLANSOPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE;ORAL60MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009RXYes9,011,926► subscribeY ► subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009RXYes6,939,971*PED► subscribeY► subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009RXYes8,461,187*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: dexlansoprazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 20095,093,132*PED► subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 20095,045,321*PED► subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 20095,433,959*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: dexlansoprazole

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
7,070,805Rapidly disintegrable solid preparation► subscribe
8,884,019Benzimidazole compound crystal► subscribe
7,737,282Benzimidazole compound crystal► 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 Ingredient: dexlansoprazole

Country Document Number Estimated Expiration
TaiwanI289557► subscribe
Austria481090► subscribe
Austria511508► 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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Supplementary Protection Certificates for Tradename: DEXLANSOPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088/01Switzerland► subscribePRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
2014014,C1129088Lithuania► subscribePRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
14/008Ireland► subscribePRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
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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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