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Last Updated: April 25, 2024

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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Teduglutide recombinant has eight patent family members in seven countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for teduglutide recombinant
Generic Entry Date for teduglutide recombinant*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
Dosage:
POWDER;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for teduglutide recombinant

Country Patent Number Title Estimated Expiration
European Patent Office 1809318 TRAITEMENT DE PATIENTS ATTEINTS DU SYNDROME DE L'INTESTIN COURT AVEC COLON EN CONTINUITE (TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006050244 ⤷  Try a Trial
Spain 2427150 ⤷  Try a Trial
Hong Kong 1107026 TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY ⤷  Try a Trial
Denmark 1809318 ⤷  Try a Trial
Japan 5197012 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for teduglutide recombinant

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