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Last Updated: December 4, 2022

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 Takeda Pharms Usa and is included in one NDA. There are three 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.

One supplier is listed for this compound.

Recent Clinical Trials for teduglutide recombinant

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

SponsorPhase
Allegheny Singer Research InstitutePhase 3
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 3
Takeda Development Center Americas, Inc.Phase 1

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
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes 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

Supplementary Protection Certificates for teduglutide recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0906338 92153 Luxembourg See Plans and Pricing PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338 13C0013 France See Plans and Pricing PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 C300578 Netherlands See Plans and Pricing 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:

Medtronic
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McKesson
AstraZeneca
Baxter
Moodys

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