TEDUGLUTIDE - Generic Drug Details

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

Teduglutide 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 has eight patent family members in seven countries.

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

Summary for TEDUGLUTIDE

International Patents:	8
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	35
Patent Applications:	618
What excipients (inactive ingredients) are in TEDUGLUTIDE?	TEDUGLUTIDE excipients list
DailyMed Link:	TEDUGLUTIDE at DailyMed

Recent Clinical Trials for TEDUGLUTIDE

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

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

See all TEDUGLUTIDE clinical trials

Pharmacology for TEDUGLUTIDE

Ingredient-type	Analogs/Derivatives Glucagon-Like Peptide 2
Drug Class	GLP-2 Analog
Mechanism of Action	Glucagon-like Peptide-2 (GLP-2) Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TEDUGLUTIDE

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for TEDUGLUTIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GATTEX KIT	Injection	teduglutide	5 mg/vial	203441	1	2016-12-21

US Patents and Regulatory Information for TEDUGLUTIDE

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Glossary

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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	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
Japan	2008518941		⤷ Sign Up
Denmark	1809318		⤷ Sign Up
Hong Kong	1107026	TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TEDUGLUTIDE

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

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