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Last Updated: September 25, 2020

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Dexlansoprazole - Generic Drug Details

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What are the generic sources for dexlansoprazole and what is the scope of patent protection?

Dexlansoprazole is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and Par Pharm Inc, and is included in three NDAs. There are seventeen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has two hundred and twenty-six patent family members in forty-two countries.

There are seventeen drug master file entries for dexlansoprazole. Three suppliers are listed for this compound.

Recent Clinical Trials for dexlansoprazole

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

SponsorPhase
Taipei Veterans General Hospital, TaiwanN/A
Vanderbilt UniversityEarly Phase 1
Washington University School of MedicineEarly Phase 1

See all dexlansoprazole clinical trials

Pharmacology for dexlansoprazole
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for dexlansoprazole
Paragraph IV (Patent) Challenges for DEXLANSOPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
DEXILANT CAPSULE, DELAYED RELEASE;ORAL dexlansoprazole 022287 2010-11-30

US Patents and Regulatory Information for dexlansoprazole

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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 dexlansoprazole

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

Supplementary Protection Certificates for dexlansoprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 122014000036 Germany   Start Trial 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 1490004-7 Sweden   Start Trial PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
1129088 PA2014014 Lithuania   Start Trial 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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