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Last Updated: December 1, 2020

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DEXILANT SOLUTAB Drug Profile

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When do Dexilant Solutab patents expire, and when can generic versions of Dexilant Solutab launch?

Dexilant Solutab is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and eighty-seven patent family members in forty-one countries.

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

US ANDA Litigation and Generic Entry Outlook for Dexilant Solutab

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

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Summary for DEXILANT SOLUTAB
Drug patent expirations by year for DEXILANT SOLUTAB

US Patents and Regulatory Information for DEXILANT SOLUTAB

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   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 SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No   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 DEXILANT SOLUTAB

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   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DEXILANT SOLUTAB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 C01129088/01 Switzerland   Start Trial PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088 2014/008 Ireland   Start 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
1129088 C 2014 021 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Express Scripts
McKesson
Colorcon
Harvard Business School

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