Gattex Kit Patent Expiration

Gattex Kit is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 42 US drug patents filed from 2013 to 2019. Out of these, 38 drug patents are active and 4 have expired. Gattex Kit's patents have been open to challenges since 22 June, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be May 16, 2026. Details of Gattex Kit's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9060992

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9592274

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9592273

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9572867

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9987335

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9993528

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9545434

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9555079

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9981016

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9968658

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9974835

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9974837

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9968656

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9968655

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9987334

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9981014

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9539310

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9545435

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US7847061

(Pediatric)

Treatment of short bowel syndrome patients with colon-in-continuity
May, 2026

(1 year, 4 months from now)

Active
US9968655 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9060992 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US7847061 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9981014 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9993528 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9981016 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9974837 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9968658 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9987335 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9545435 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9545434 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9968656 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9539310 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9572867 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9974835 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9592273 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9592274 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9555079 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US9987334 Treatment of short bowel syndrome patients with colon-in-continuity
Nov, 2025

(10 months from now)

Active
US7056886

(Pediatric)

GLP-2 formulations
Mar, 2023

(1 year, 8 months ago)

Expired
US7056886 GLP-2 formulations
Sep, 2022

(2 years ago)

Expired
US5789379

(Pediatric)

Glucagon-like peptide-2 analogs
Oct, 2020

(4 years ago)

Expired
US5789379 Glucagon-like peptide-2 analogs
Apr, 2015

(9 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gattex Kit's patents.

Given below is the list of recent legal activities going on the following patents of Gattex Kit.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 16 Nov, 2022 US9060992 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 19 May, 2022 US7847061 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 17 Nov, 2021 US9987335 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 17 Nov, 2021 US9987334
Payment of Maintenance Fee, 4th Year, Large Entity 17 Nov, 2021 US9993528
Payment of Maintenance Fee, 4th Year, Large Entity 21 Oct, 2021 US9974837 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 21 Oct, 2021 US9974835
Payment of Maintenance Fee, 4th Year, Large Entity 21 Oct, 2021 US9981016 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 21 Oct, 2021 US9968655
Payment of Maintenance Fee, 4th Year, Large Entity 21 Oct, 2021 US9968656 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Gattex Kit and ongoing litigations to help you estimate the early arrival of Gattex Kit generic.

Gattex Kit's Litigations

Gattex Kit been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 23, 2015, against patent number US7056886. The petitioner Coalition for Affordable Drugs II, LLC, challenged the validity of this patent, with NPS Pharmaceuticals, Inc. et al. as the respondent. Click below to track the latest information on how companies are challenging Gattex Kit's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7056886 April, 2015 Final Written Decision
(21 Oct, 2016)
NPS Pharmaceuticals, Inc. et al. Coalition for Affordable Drugs II LLC
US7056886 April, 2015 Final Written Decision
(21 Oct, 2016)
NPS Pharmaceuticals, Inc. et al. Coalition for Affordable Drugs II, LLC


FDA has granted some exclusivities to Gattex Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gattex Kit, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gattex Kit.

Exclusivity Information

Gattex Kit holds 5 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Gattex Kit's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 21, 2017
Orphan Drug Exclusivity(ODE) Dec 21, 2019
Orphan Drug Exclusivity(ODE-37) Dec 21, 2019
Pediatric Exclusivity(PED) Jun 21, 2020
Orphan Drug Exclusivity(ODE-240) May 16, 2026

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Gattex Kit is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gattex Kit's family patents as well as insights into ongoing legal events on those patents.

Gattex Kit's Family Patents

Gattex Kit has patent protection in a total of 12 countries. It has a significant patent presence in the US with 82.1% of its patents being US patents. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Gattex Kit.

Family Patents

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Generic Launch

Generic Release Date:

Gattex Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 16, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Gattex Kit Generics:

There are no approved generic versions for Gattex Kit as of now.





About Gattex Kit

Gattex Kit is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating adult patients with short bowel syndrome who depend on parenteral support. Gattex Kit uses Teduglutide as an active ingredient. Gattex Kit was launched by Takeda Pharms Usa in 2012.

Approval Date:

Gattex Kit was approved by FDA for market use on 21 December, 2012.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Gattex Kit is 21 December, 2012, its NCE-1 date is estimated to be 22 June, 2019.

Active Ingredient:

Gattex Kit uses Teduglutide as the active ingredient. Check out other Drugs and Companies using Teduglutide ingredient

Treatment:

Gattex Kit is used for treating adult patients with short bowel syndrome who depend on parenteral support.

Dosage:

Gattex Kit is available in powder form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
5MG/VIAL POWDER Prescription SUBCUTANEOUS