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Last Updated: February 3, 2023

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

Dexlansoprazole has two hundred patent family members in forty-one countries.

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

Summary for dexlansoprazole
Recent Clinical Trials for dexlansoprazole

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

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

See all dexlansoprazole clinical trials

Pharmacology for dexlansoprazole
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Par Pharm Inc DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202294-002 Jun 16, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes 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
>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 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dexlansoprazole

Country Patent Number Title Estimated Expiration
Germany 60038481 See Plans and Pricing
Japan 5330967 See Plans and Pricing
European Patent Office 2203068 PROCÉDÉS DE TRAITEMENT DE TROUBLES GASTRO-INTESTINAUX INDÉPENDANTS DE LA PRISE ALIMENTAIRE (METHODS OF TREATING GASTROINTESTINAL DISORDERS INDEPENDENT OF THE INTAKE OF FOOD) See Plans and Pricing
Morocco 27456 PREPARATION A LIBERATION CONTROLEE See Plans and Pricing
>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 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 PA2014014 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
1129088 C01129088/01 Switzerland See Plans and Pricing PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088 2014C/017 Belgium See Plans and Pricing PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023
>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.