Viewing data from:

GATTEX KIT

NDA

TEDUGLUTIDE | N203441 | TAKEDA PHARMACEUTICALS USA INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents (2 delisted), 1 exclusivity by expiration date

Expired (2)TodayPED (+6 mo)ExclusivityDelisted

2 patents delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2026

Today

7847061

May. 1, 2026Delisted

9060992

May. 1, 2026Delisted

ODE-240

May. 16, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Shire-NPS Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc. et al 1:2018cv01115	D. Del.	2018-07-28	Terminated 2018-11-26	—
Shire-NPS Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc., et al 1:2017cv00397	D. Del.	2017-04-10	Terminated 2018-11-26	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

31 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function NCT01028768	Phase 1	Completed	Nycomed	36	2009-10 → 2010-03
Effect of Teduglutide on Gastric Emptying in Healthy Subjects NCT01209351	Phase 1	Completed	Shire	36	2010-09-28 → 2010-11-08
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients NCT03562130	Phase 4	Completed	Assistance Publique - Hôpitaux de Paris	25	2018-07-02 → 2020-07-13
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 NCT01560403	Phase 3	Completed	Shire	14	2012-05-21 → 2013-07-23
Study of Teduglutide in Japanese Participants With Short Bowel Syndrome NCT03663582	Phase 3	Completed	Shire	7	2018-07-06 → 2019-08-06
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support NCT02980666	Phase 3	Completed	Shire	10	2017-01-13 → 2020-01-21
A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide NCT00820885	Phase 1	Completed	Shire	95	2006-09-06 → 2007-04-23
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)NCT02340819	Phase 3	Completed	Shire	11	2014-12-18 → 2018-11-05
L-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release NCT03534661	Phase 2/3	Completed	University Health Network, Toronto	10	2017-09-27 → 2019-03-20
Teduglutide for Enterocutaneous Fistula (ECF)NCT02889393	Phase 2	Completed	Daniel Dante Yeh	6	2019-01-31 → 2021-07-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$1242.20

Highest Price

$34605.34

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68875-0103-01GATTEX 5MG INJ, 1 VIAL KIT	$1242.20	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
68875-0102-01GATTEX 5MG INJ, 30 VIAL KIT	$34605.34	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Gattex (2024)

Total Spending

$357.6M

Total Claims

7,085

Beneficiaries

962

Avg Cost/Unit

$38030.01

Spending Trend

$277.4M(2019)→$297.3M(2020)→$294.3M(2021)→$297.1M(2022)→$330.4M(2023)→$357.6M(2024)

YoY Change:+5.9%

5yr CAGR:-1.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

AMBIO INCTEDUGLUTIDE NON-STERILE

DMF 305832016

ALP PHARM BEIJING CO LTDTEDUGLUTIDE

DMF 354382020

MSN LIFE SCIENCES PRIVATE LTDTEDUGLUTIDE

DMF 375962022

OLON SPATEDUGLUTIDE

DMF 432912026

BIOCON LTDTEDUGLUTIDE

DMF 439102026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Sep 8, 2025	SUPPL -24	View Letter (PDF)
Aug 15, 2025	SUPPL -23	View Letter (PDF)
Feb 22, 2024	SUPPL -21	View Letter (PDF)
Jan 25, 2023	SUPPL -16	View Letter (PDF)
Feb 16, 2021	SUPPL -20	View Letter (PDF)
Feb 2, 2021	SUPPL -18	View Letter (PDF)
Jul 20, 2020	SUPPL -19	View Letter (PDF)
May 21, 2019	SUPPL -13	View Letter (PDF)
Dec 21, 2018	SUPPL -12	View Letter (PDF)
Mar 24, 2017	SUPPL -10	View Letter (PDF)
May 31, 2016	SUPPL -8	View Letter (PDF)
Jun 27, 2014	SUPPL -2	View Letter (PDF)
Dec 27, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/VIAL

RLD

2 patents1 exclusivity▴

POWDER;SUBCUTANEOUS | Approved: Dec 21, 2012

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7847061	Nov 1, 2025PED: May 1, 2026	PED	—	—		Delisted
9060992	Nov 1, 2025PED: May 1, 2026	PED	—	—		Delisted

Exclusivities (1)

Code	Date	Status
ODE-240	May 16, 2026	Expired