Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

DrugPatentWatch Database Preview

GATTEX KIT Drug Profile

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When do Gattex Kit patents expire, and when can generic versions of Gattex Kit launch?

Gattex Kit is a drug marketed by Nps Pharms Inc and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in eighteen countries.

The generic ingredient in GATTEX KIT is teduglutide recombinant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide recombinant profile page.

Drug patent expirations by year for GATTEX KIT
Generic Entry Opportunity Date for GATTEX KIT
Generic Entry Date for GATTEX KIT*:
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
NDA:
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 GATTEX KIT

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

SponsorPhase
Allegheny Singer Research InstitutePhase 3
Massachusetts General HospitalPhase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 2

See all GATTEX KIT clinical trials

Recent Litigation for GATTEX KIT

Identify potential future generic entrants

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

See all GATTEX KIT litigation

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

See all GATTEX KIT litigation

Pharmacology for GATTEX KIT

US Patents and Regulatory Information for GATTEX KIT

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   See Pricing   See Pricing Y   See Pricing
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   See Pricing   See Pricing   See Pricing
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for GATTEX KIT
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 5 mg/vial ➤ Subscribe   See Pricing

Supplementary Protection Certificates for GATTEX KIT

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