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Last Updated: May 28, 2024

DEXILANT Drug Patent 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 twelve patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dexilant

A generic version of DEXILANT was approved as dexlansoprazole by PAR PHARM INC on April 19th, 2017.

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Drug patent expirations by year for DEXILANT
Drug Prices for DEXILANT

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Drug Sales Revenue Trends for DEXILANT

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Recent Clinical Trials for DEXILANT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of KarachiPhase 1
SAMI Pharmaceutical, Karachi PakistanPhase 1
Taipei Veterans General Hospital, TaiwanN/A

See all DEXILANT clinical trials

Pharmacology for DEXILANT
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Paragraph IV (Patent) Challenges for DEXILANT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DEXILANT Delayed-release Capsules dexlansoprazole 30 mg 022287 1 2010-11-30

US Patents and Regulatory Information for DEXILANT

DEXILANT is protected by seven US patents.

Patents protecting DEXILANT

Multiple PPI dosage form
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Controlled release preparation
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Controlled release preparation
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Method for producing granules
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Method for producing granules
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Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy
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Patented Use: USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS

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

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

International Patents for DEXILANT

See the table below for patents covering DEXILANT around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0446961 Composition pharmaceutique stabilisée et sa préparation (Stabilized pharmaceutical composition and its production) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2004035020 ⤷  Sign Up
Spain 2300265 ⤷  Sign Up
Slovenia 1553929 ⤷  Sign Up
Australia 1850602 ⤷  Sign Up
Israel 145996 BENZIMIDAZOLE COMPOUND CRYSTAL ⤷  Sign Up
South Korea 20100116165 METHODS OF TREATING GASTROINTESTINAL DISORDERS INDEPENDENT OF THE INTAKE OF FOOD ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DEXILANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 2014/008 Ireland ⤷  Sign Up 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
1129088 PA2014014 Lithuania ⤷  Sign Up 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
1129088 C 2014 021 Romania ⤷  Sign Up PRODUCT NAME: DEXLANSOPRAZOL(R)-2-([3-METIL-4-(2,2,2-TRIFLUOROETOXI)PIRIDIN-2-IL]METILSULFINIL)-1H-BENZIMIDAZOL; NATIONAL AUTHORISATION NUMBER: RO6090/2014/01, RO6090/2014/02; DATE OF NATIONAL AUTHORISATION: 20140120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SE 47911; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1129088 1490004-7 Sweden ⤷  Sign Up PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
1129088 C01129088/01 Switzerland ⤷  Sign Up PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088 122014000036 Germany ⤷  Sign Up 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 PA2014014,C1129088 Lithuania ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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