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DEXILANT Drug Profile

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Which patents cover Dexilant, and what substitute generic drugs are available?

Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are twenty-one patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-three patent family members in thirty-one countries.

The generic ingredient in DEXILANT is dexlansoprazole. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the dexlansoprazole profile page.

Summary for Tradename: DEXILANT

Patents:15
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Bulk Api Vendors: see list28
Clinical Trials: see list15
Patent Applications: see list99
Drug Prices:see details
DailyMed Link:DEXILANT at DailyMed

Pharmacology for Tradename: DEXILANT

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016RXYesYes6,328,994*PED► SubscribeY► Subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009RXYesYes8,461,187*PED► SubscribeY► Subscribe
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016RXYesYes8,461,187*PED► SubscribeY► Subscribe
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016RXYesYes7,285,668*PED► SubscribeY► Subscribe
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016RXYesYes8,871,273*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: DEXILANT

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, 20095,093,132*PED► Subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 20095,433,959*PED► Subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 20095,433,959*PED► Subscribe
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Paragraph IV activity for: DEXILANT

Drugname Dosage Strength RLD Submissiondate
dexlansoprazoleDelayed-release Capsule30 mgDexilant11/30/2010
dexlansoprazoleCapsule60 mgDexilant8/25/2010

Non-Orange Book Patents for Tradename: DEXILANT

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
7,339,064Benzimidazole compound crystal► Subscribe
8,884,019Benzimidazole compound crystal► Subscribe
7,569,697Benzimidazole compound crystal► Subscribe
8,552,198Benzimidazole compound crystal► Subscribe
8,030,333Benzimidazole 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 Tradename: DEXILANT

Country Document Number Estimated Expiration
Japan3283252► Subscribe
Canada2599340► Subscribe
Japan5756548► Subscribe
European Patent Office1977751► Subscribe
Hungary0400781► 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: DEXILANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014014Lithuania► 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
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
90004-7Sweden► SubscribePRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
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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