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Last Updated: May 19, 2022

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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-eight patent family members in thirty-four countries.

The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Four 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

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

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Pharmacology for DEXILANT
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 eight US patents.

Patents protecting DEXILANT

Benzimidazole compound crystal
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Multiple PPI dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for producing granules
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for producing granules
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS

Multiple PPI dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DEXILANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 2014/008 Ireland See Plans and Pricing 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 1490004-7 Sweden See Plans and Pricing PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
1129088 PA2014014,C1129088 Lithuania See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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