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
(5 months from now) | Active |
|
US9592274 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9592273 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9572867 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9987335 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9993528 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9545434 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9555079 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9981016 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9968658 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9974835 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9974837 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9968656 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9968655 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9987334 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9981014 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9539310 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US9545435 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
|
US7847061 (Pediatric) | Treatment of short bowel syndrome patients with colon-in-continuity |
May, 2026
(5 months from now) | Active |
| US9968655 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9981014 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9060992 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US7847061 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9993528 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9981016 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9974837 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9968658 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9987335 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9545435 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9545434 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9968656 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9539310 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9572867 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9974835 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9592273 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9592274 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9555079 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
| US9987334 | Treatment of short bowel syndrome patients with colon-in-continuity |
Nov, 2025
(a day from now) | Active |
|
US7056886 (Pediatric) | GLP-2 formulations |
Mar, 2023
(2 years ago) |
Expired
|
| US7056886 | GLP-2 formulations |
Sep, 2022
(3 years ago) |
Expired
|
|
US5789379 (Pediatric) | Glucagon-like peptide-2 analogs |
Oct, 2020
(5 years ago) |
Expired
|
| US5789379 | Glucagon-like peptide-2 analogs |
Apr, 2015
(10 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.
Latest 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 |
|---|---|---|
 | ||
| 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 |