GATTEX KIT Drug Patent Profile

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

Gattex Kit is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Gattex Kit

Gattex Kit was eligible for patent challenges on December 21, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 16, 2026. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GATTEX KIT

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GATTEX KIT
DailyMed Link:	GATTEX KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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:

203441

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

Sponsor	Phase
Napo Pharmaceuticals, Inc.	EARLY_PHASE1
Lindsey Russell, MD	EARLY_PHASE1
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3

See all GATTEX KIT clinical trials

Pharmacology for GATTEX KIT

Ingredient-type	Analogs/Derivatives Glucagon-Like Peptide 2
Drug Class	GLP-2 Analog
Mechanism of Action	Glucagon-like Peptide-2 (GLP-2) Agonists

Paragraph IV (Patent) Challenges for GATTEX KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GATTEX KIT	Injection	teduglutide	5 mg/vial	203441	1	2016-12-21

US Patents and Regulatory Information for GATTEX KIT

GATTEX KIT is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes					Y
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes					Y
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes

International Patents for GATTEX KIT

See the table below for patents covering GATTEX KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1147761
Japan	2008184465	GLUCAGON-LIKE PEPTIDE-2 ANALOG
Japan	5604463
Hong Kong	1107026	TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY
Spain	2351661
Portugal	1246639
Hong Kong	1050142

Supplementary Protection Certificates for GATTEX KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0906338	2013/006	Ireland		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	433	Finland
0906338	1390009-7	Sweden		PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
0906338	CA 2013 00012	Denmark
0906338	13C0013	France		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	C300578	Netherlands		PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	92153	Luxembourg		PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE

Market Dynamics and Financial Trajectory for GATTEX KIT

Last updated: August 21, 2025

Introduction

GATTEX KIT (brand name: Teduglutide) represents a groundbreaking therapeutic option in the management of adult patients with Short Bowel Syndrome (SBS), a rare and complex condition characterized by malabsorption due to significant intestinal loss. Approved by the U.S. Food and Drug Administration (FDA) in 2012 and subsequently gaining regulatory approval in multiple jurisdictions, GATTEX KIT has carved a niche within the specialized segment of gastrointestinal therapies. This analysis examines the evolving market landscape, competitive positioning, regulatory influences, and the financial trajectory shaping the future prospects of GATTEX KIT.

Market Overview and Epidemiological Context

SBS prevalence remains low, with estimates of approximately 10,000 to 20,000 patients in the U.S. alone, according to industry reports [1]. However, the clinical burden is substantial, rendering patients dependent on parenteral nutrition (PN) and entailing high healthcare costs. The unmet medical need stimulated the development of innovative pharmacotherapies aimed at enhancing intestinal adaptation and reducing PN dependence.

GATTEX KIT, as the first approved glucagon-like peptide-2 (GLP-2) analog, significantly improves intestinal absorption, thereby decreasing PN requirements. It caters to a highly specialized segment, yet its potential expansion into related indications (e.g., pediatric SBS, other malabsorptive conditions) suggests a broader market horizon.

Market Dynamics

Regulatory Landscape

Regulatory bodies, notably the FDA and European Medicines Agency (EMA), have granted approval based on robust clinical trial data demonstrating GATTEX’s efficacy in reducing PN volume and improving quality of life. The orphan drug designation afforded to TEDUGLUTIDE provides market exclusivity of seven years in the U.S. post-approval, incentivizing continued investment but also shaping pricing and access strategies [2].

Updated guidelines from organizations such as the American Society for Parenteral and Enteral Nutrition (ASPEN) recognize GATTEX as a standard of care for SBS management, facilitating its incorporation into clinical practice. Regulatory developments, including potential labeling extensions and expanded indications, could further influence demand.

Market Penetration and Adoption

Despite its clinical benefits, GATTEX KIT faces barriers such as high costs (~$30,000 per month) and the necessity for lifelong administration, which can limit widespread adoption. Payers weigh the high upfront treatment costs against the long-term savings from reduced PN dependence and complication management.

Physician awareness and experience remain pivotal; initially, prescribing rates are concentrated among specialized gastroenterologists and SBS centers. Broader adoption depends on analyst-driven evidence and health economic evaluations demonstrating value propositions to insurance providers.

Competitive Landscape

Currently, GATTEX is the primary pharmacological therapy approved for SBS, providing a strong market position with minimal direct competition. However, emerging therapies include:

• MD-100: An under-development oral GLP-2 analog aiming to offer an alternative route of administration [3].
• Other biological agents: Experimental therapies focusing on intestinal regeneration and microbiota modulation might alter future competition scenarios.

Furthermore, continued innovation in surgical techniques and personalized nutrition management impacts the market dynamics, potentially influencing GATTEX KIT’s share.

Pricing and Reimbursement Trends

Reimbursement policies significantly influence GATTEX KIT's financial trajectory. As an orphan drug, the pricing paradigm emphasizes premium pricing structures. Managed care organizations increasingly scrutinize reimbursement decisions; demonstrating cost-effectiveness through pharmacoeconomic studies is crucial.

Global pricing varies, constrained by healthcare system constraints, with notable markets including the U.S., Europe, and select Asian countries. Payers in these regions are progressively requiring registries and real-world evidence to justify ongoing payment.

Innovation and Pipeline Developments

Research efforts focus on optimizing dosing regimens, alternative formulations, and combination therapies to improve efficacy and adherence. The development pipeline includes:

• Long-acting formulations: To reduce administration frequency.
• Bi-specific agents: Combining GLP-2 activity with other gastrointestinal growth factors.

These innovations could enhance market penetration and patient compliance, positively impacting sales.

Financial Trajectory

Historical Revenue and Sales Trends

Since its launch, GATTEX KIT’s sales have demonstrated steady growth, driven by increasing awareness and expanded indications. In 2020, sales exceeded several hundred million dollars globally, with the U.S. accounting for approximately 80% of revenue, reflecting the drug’s primary adoption in the domestic market [4].

Forecasting Future Revenue

Industry analysts project compounded annual growth rates (CAGRs) of approximately 8-12% over the next five years, considering factors such as:

• Increasing adoption within existing SBS patient populations.
• Expansion into pediatric indications and other malabsorptive conditions.
• Broader international market penetration, especially in Europe and Asia-Pacific.

The outlook assumes continued regulatory support and favorable pricing negotiations, alongside growing clinical awareness.

Impact of Market Exclusivity and Patent Landscape

GATTEX KIT benefits from orphan-drug exclusivity, limiting generic competition during the protection period. Post-expiry, potential biosimilar entrants could exert downward pressure on prices and sales. Strategic patent extensions and labeling protections remain vital for maintaining revenue streams.

Potential Disruptors

Emerging therapies, technological advances in surgical and nutritional management, and changes in healthcare reimbursement policies could impact earnings. The advent of oral GLP-2 analogs or gene therapy approaches might challenge current market shares.

Strategic Outlook and Recommendations

For industry stakeholders, the key to maximizing GATTEX KIT’s financial potential lies in:

• Strengthening clinical evidence bases to support broader indications and cost-effectiveness claims.
• Engaging payers early to negotiate favorable reimbursement terms.
• Investing in patient support programs to enhance adherence.
• Exploring strategic collaborations to accelerate pipeline innovation.

Key Takeaways

• The GATTEX KIT market is characterized by a niche but vital segment addressing unmet needs in SBS management.
• Market growth depends on regulatory support, physician adoption, and favorable reimbursement dynamics.
• Competitive landscape remains limited, but pipeline innovations and biosimilar developments pose future threats.
• Robust pharmacoeconomic data and international expansion strategies are critical for sustaining revenue growth.
• Post-exclusivity scenarios require proactive patent management and pipeline diversification to safeguard profitability.

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FAQs

1. What are the primary drivers of GATTEX KIT's market growth?
Increased clinical adoption, expanded indications, positive reimbursement policies, and ongoing pipeline developments are key growth drivers.

2. How does reimbursement impact GATTEX KIT’s sales trajectory?
Reimbursement policies directly influence affordability for patients and hospitals. Favorable coverage facilitates higher adoption, while restrictive policies can hamper sales.

3. What competitive threats could impact GATTEX KIT's market share?
Emerging oral GLP-2 therapies, biosimilars post-patent expiration, and alternative surgical or nutritional approaches could reduce market dominance.

4. How does the orphan drug designation affect GATTEX KIT’s financial prospects?
It grants market exclusivity, enabling premium pricing and limited competition, which sustains revenues during the protection period.

5. What strategies should industry players pursue to capitalize on GATTEX KIT’s potential?
Focusing on clinical evidence, broadening indications, engaging payers, and pipeline innovation are essential strategies.

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References

[1] [Industry Reports on SBS Epidemiology]
[2] [FDA Orphan Drug Program: GATTEX TEDUGLUTIDE]
[3] [Pipeline Data from Clinical Trials Registry]
[4] [Company Annual Reports and Market Analysis Publications]