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Serving leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
Chubb
Queensland Health
Harvard Business School
Mallinckrodt
Farmers Insurance
Julphar
Express Scripts
Accenture

Generated: January 16, 2018

DrugPatentWatch Database Preview

DEXILANT Drug Profile

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Which patents cover Dexilant, and what generic alternatives 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 fifty patent family members in thirty-one countries and six supplementary protection certificates in five 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. Additional details are available on the dexlansoprazole profile page.
Summary for DEXILANT
International Patents:150
US Patents:15
Applicants:1
NDAs:2
Suppliers / Packagers: 3
Bulk Api Vendors: 35
Clinical Trials: 16
Patent Applications: 103
Drug Prices:see details
DailyMed Link:DEXILANT at DailyMed
Drug patent expirations by year for DEXILANT
Pharmacology for DEXILANT
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for DEXILANT

US Patents and Regulatory Information for DEXILANT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for DEXILANT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for DEXILANT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Capsule 30 mg ➤ Subscribe 11/30/2010
➤ Subscribe Capsule 60 mg ➤ Subscribe 8/25/2010

Non-Orange Book US Patents for 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
8,552,198 Benzimidazole compound crystal ➤ Subscribe
7,339,064 Benzimidazole compound crystal ➤ Subscribe
7,569,697 Benzimidazole compound crystal ➤ Subscribe
8,884,019 Benzimidazole compound crystal ➤ Subscribe
8,030,333 Benzimidazole compound crystal ➤ Subscribe
7,737,282 Benzimidazole compound crystal ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for DEXILANT

Supplementary Protection Certificates for DEXILANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/008 Ireland ➤ Subscribe PRODUCT 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
90004-7 Sweden ➤ Subscribe PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
2014014,C1129088 Lithuania ➤ Subscribe PRODUCT 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
2014000036 Germany ➤ Subscribe PRODUCT NAME: KRISTALLINE FORM DES (R)-2-(((3-METHYL-4-(2,2,2-TRIFLUORETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAOLS; NAT. REGISTRATION NO/DATE: 87192.00.00 87193.00.00 87194.00.00 87195.00.00 20131118 FIRST REGISTRATION: SCHWEDEN 47911 47912 47913 47914 20130919
1129088/01 Switzerland ➤ Subscribe PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
2014014 Lithuania ➤ Subscribe PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Moodys
Teva
McKesson
Healthtrust
AstraZeneca
Cipla
Boehringer Ingelheim

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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