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Last Updated: November 13, 2019

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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.

Recent Clinical Trials for teduglutide recombinant

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

SponsorPhase
Allegheny Singer Research InstitutePhase 3
Queen Mary University of LondonPhase 2
Imagine InstitutePhase 4

See all teduglutide recombinant clinical trials

Recent Litigation for teduglutide recombinant

Identify potential future generic entrants

District Court Litigation
Case NameDate
Shire-NPS Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc.2018-07-28

See all teduglutide recombinant litigation

PTAB Litigation
PetitionerDate
Coalition for Affordable Drugs II, LLC2015-04-23
Coalition for Affordable Drugs II LLC2015-04-01

See all teduglutide recombinant litigation

Pharmacology for teduglutide recombinant
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   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 C300578 Netherlands   Start Trial PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 13C0013 France   Start Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 92153 Luxembourg   Start Trial PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338 433 Finland   Start Trial
0906338 CA 2013 00012 Denmark   Start Trial
0906338 2013/006 Ireland   Start Trial 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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