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Last Updated: September 16, 2021

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Teduglutide recombinant - Generic Drug Details

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What are the generic drug sources for teduglutide recombinant and what is the scope of freedom to operate?

Teduglutide recombinant is the generic ingredient in one branded drug marketed by Nps Pharms Inc and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Teduglutide recombinant has twenty-six patent family members in twelve countries.

There is one drug master file entry for teduglutide recombinant. One supplier is listed for this compound.

Recent Clinical Trials for teduglutide recombinant

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

SponsorPhase
TakedaPhase 3
Takeda Development Center Americas, Inc.Phase 1
Allegheny Singer Research InstitutePhase 3

See all teduglutide recombinant clinical trials

Pharmacology for teduglutide recombinant

US Patents and Regulatory Information for teduglutide recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for teduglutide recombinant

Country Patent Number Estimated Expiration
Portugal 1246639 ⤷  Free Forever Trial
Japan 2003519195 ⤷  Free Forever Trial
Japan 2008518941 ⤷  Free Forever Trial
Japan 2014159463 ⤷  Free Forever Trial
Spain 2427150 ⤷  Free Forever Trial
Hong Kong 1050142 ⤷  Free Forever Trial
European Patent Office 1246639 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for teduglutide recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0906338 2013/006 Ireland ⤷  Free Forever Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 92153 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338 13C0013 France ⤷  Free Forever Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 C300578 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Moodys
McKesson
Johnson and Johnson
Dow

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