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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 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 twenty-one 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:	21
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	32
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for teduglutide recombinant
DailyMed Link:	teduglutide recombinant at DailyMed

Recent Clinical Trials for teduglutide recombinant

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

Sponsor	Phase
Allegheny Singer Research Institute	Phase 3
Queen Mary University of London	Phase 2
Imagine Institute	Phase 4

See all teduglutide recombinant clinical trials

Recent Litigation for teduglutide recombinant

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Shire-NPS Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc.	2018-07-28

See all teduglutide recombinant litigation

PTAB Litigation

Petitioner	Date
Coalition for Affordable Drugs II, LLC	2015-04-23
Coalition for Affordable Drugs II LLC	2015-04-01

See all teduglutide recombinant litigation

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

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

International Patents for teduglutide recombinant

Country	Patent Number	Estimated Expiration
European Patent Office	0906338
Austria	353665
Japan	4148994
Japan	4149497
Japan	2006342172
Japan	2010159259

Supplementary Protection Certificates for teduglutide recombinant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0906338	C300578	Netherlands		PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	13C0013	France		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	92153	Luxembourg		PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338	433	Finland
0906338	CA 2013 00012	Denmark
0906338	2013/006	Ireland		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830