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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 teduglutide recombinant patent protection?

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

Teduglutide recombinant has eighty-two patent family members in eighteen countries.

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

Summary for teduglutide recombinant

International Patents:	82
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	22
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	teduglutide recombinant at DailyMed

Pharmacology for teduglutide recombinant

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

Synonyms for teduglutide recombinant

BDBM50183895

CHEBI:72305

CHEMBL2104987

revestive

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
Nps Pharms Inc	GATTEX KIT	teduglutide recombinant	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes			Y
Nps Pharms Inc	GATTEX KIT	teduglutide recombinant	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes
Nps Pharms Inc	GATTEX KIT	teduglutide recombinant	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes

Non-Orange Book US Patents for teduglutide recombinant

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,184,201	Intestinotrophic glucagon-like peptide-2 analogs
7,049,284	Glucagon-like peptide-2 and its therapeutic use
7,781,401	Glucagon-like peptide-2 analogs
5,834,428	Glucagon-like peptide-2 and its therapeutic use

International Patents for teduglutide recombinant

Country	Document Number	Estimated Expiration
Brazil	9708566
European Patent Office	2218734
Portugal	1231219
Spain	2427150

Supplementary Protection Certificates for teduglutide recombinant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00578	Netherlands		PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
3	Finland
13/006	Ireland		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
2013 00012	Denmark