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Last Updated: March 29, 2024

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, Mylan, Par Pharm Inc, and Twi Pharms, and is included in five NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has one hundred and fifty-one patent family members in thirty-eight countries.

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

Drug Prices for dexlansoprazole

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Recent Clinical Trials for dexlansoprazole

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 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 Strength NDA ANDAs Submitted Submissiondate
DEXILANT Delayed-release Capsules dexlansoprazole 30 mg 022287 1 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 022287-002 Jan 30, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dexlansoprazole

Country Patent Number Title Estimated Expiration
Canada 2737851 PREPARATION A LIBERATION CONTROLEE (CONTROLLED RELEASE PREPARATION) ⤷  Try a Trial
China 1713897 Sustained release preparation ⤷  Try a Trial
Canada 2702356 PROCEDES DE TRAITEMENT DE TROUBLES GASTRO-INTESTINAUX INDEPENDANTS DE LA PRISE ALIMENTAIRE (METHODS OF TREATING GASTROINTESTINAL DISORDERS INDEPENDENT OF THE INTAKE OF FOOD) ⤷  Try a Trial
Australia 2005264864 Multiple PPI dosage form ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dexlansoprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 2014/008 Ireland ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.