Teduglutide - Generic Drug Details

What are the generic drug sources for teduglutide and what is the scope of patent protection?

Teduglutide is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Teduglutide has eight patent family members in seven countries.

There is one drug master file entry for teduglutide. One supplier is listed for this compound.

Summary for teduglutide

International Patents:	8
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	37
Patent Applications:	1,156
What excipients (inactive ingredients) are in teduglutide?	teduglutide excipients list
DailyMed Link:	teduglutide at DailyMed

Recent Clinical Trials for teduglutide

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

Sponsor	Phase
Takeda	PHASE3
Lindsey Russell, MD	EARLY_PHASE1
Napo Pharmaceuticals, Inc.	EARLY_PHASE1

See all teduglutide clinical trials

Pharmacology for teduglutide

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

Anatomical Therapeutic Chemical (ATC) Classes for teduglutide

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for TEDUGLUTIDE

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 teduglutide

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
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes	9,060,992*PED				Y
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes	7,847,061*PED				Y

International Patents for teduglutide

Country	Patent Number	Title	Estimated Expiration
Denmark	1809318
European Patent Office	1809318	TRAITEMENT DE PATIENTS ATTEINTS DU SYNDROME DE L'INTESTIN COURT AVEC COLON EN CONTINUITE (TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY)
Japan	2008518941
Hong Kong	1107026	TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY

Supplementary Protection Certificates for teduglutide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0906338	13C0013	France		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	2013/006	Ireland		PRODUCT NAME: TEDUGLUTIDE; 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
0906338	C300578	Netherlands		PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830

Last updated: July 31, 2025

rket Dynamics and Financial Trajectory for Teduglutide: A Comprehensive Analysis

Introduction
Teduglutide, marketed as Gattex and Revestive, is a glucagon-like peptide-2 (GLP-2) analog developed by enzyme replacement technologies (Sesen Bio, formerly by Takeda Pharmaceutical) for the treatment of short bowel syndrome (SBS). Since its FDA approval in 2012, the drug's market trajectory, competitive landscape, and growth prospects have been shaped by evolving medical needs, regulatory pathways, and commercial strategies. This analysis delineates the current market dynamics and projects the financial trajectory of teduglutide, emphasizing key drivers, challenges, and opportunities.

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Market Landscape and Patient Demographics

The primary indication for teduglutide—short bowel syndrome—primarily affects patients with massive intestinal resection, whether due to Crohn’s disease, mesenteric ischemia, or trauma. The prevalence of SBS, though relatively rare, encompasses approximately 15 to 30 per million people globally, creating a niche yet significant market segment that demands specialized therapy options [1].

The growing pool of patients eligible for teduglutide is partly driven by increased awareness, improved diagnostic capabilities, and the adoption of early intervention strategies. Notably, the aging population and rising incidence of Crohn’s disease serve as parallel tailwinds. As of 2022, the global SBS treatment market was valued at approximately $300 million, with steady CAGR projections of around 8-10% through the next decade, reflecting both unmet needs and expanding indications.

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Market Drivers

1. Unmet Medical Need and Treatment Efficacy
Teduglutide offers significant clinical benefits by promoting intestinal adaptation, reducing dependence on parenteral nutrition (PN), and improving quality of life. For many SBS patients, this translates into decreased hospitalization rates and enhanced survival, positioning teduglutide as a critical component in SBS management. As clinical data continues to substantiate its efficacy, demand surges, especially from healthcare providers emphasizing resource optimization.

2. Regulatory Approvals and Expanding Indications
Initial FDA approval targeted adult patients with SBS-dependent PN dependence. Subsequently, regulatory agencies such as EMA and Japan’s PMDA extended approvals, broadening access. Additionally, investigational trials have explored pediatric applications and the drug’s potential for other gastrointestinal disorders, fueling expectations of future indications and revenue streams.

3. Pricing, Reimbursement, and Market Access
Teduglutide’s high cost—often exceeding $300,000 annually per patient—poses reimbursement challenges but is counterbalanced by its proven ability to reduce PN costs substantially. Payers recognize the long-term economic benefits of decreased hospitalization and complication management, easing formulary integration. Strategic collaborations with payers have been pivotal for maintaining market access.

4. Competitive and Pipeline Dynamics
While currently the only approved GLP-2 analog, teduglutide faces competition from emerging therapies, such as apraglutide—a novel, synthetic GLP-2 analog with a longer half-life—potentially offering improved dosing convenience. Additionally, other gut growth factors and regenerative therapies are under investigation, but none have yet closed the gap in clinical efficacy or market penetration.

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Market Challenges

1. Cost and Reimbursement Barriers
High drug costs remain a significant barrier for widespread adoption in certain healthcare systems, especially in emerging markets. Variability in reimbursement policies impacts patient access and overall drug utilization.

2. Limited Patient Population and Market Saturation Risks
The niche nature of SBS constrains the overall market size. As most eligible patients are already treated, future growth hinges on unmet needs, off-label uses, or expansion into new indications.

3. Patent and Exclusivity Considerations
Teduglutide’s patent protection and orphan drug status confer market exclusivity until the late 2020s, but upcoming patent expirations could invite biosimilar competition, exerting downward pressure on prices and margins.

4. Clinical and Safety Considerations
Potential adverse effects, such as intestinal neoplasia, necessitate ongoing surveillance and may impact clinician prescribing behavior. Long-term safety data continues to accrue, influencing market confidence.

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Financial Trajectory and Revenue Outlook

1. Historical Performance and Current Revenue Streams
Since launch, teduglutide has achieved steady sales growth, driven by expanding indications and geographic penetration. Takeda reported revenues exceeding $200 million globally in 2021, with the majority stemming from the U.S. and European markets [2]. The revenue plateaued in recent years due to market saturation and reimbursement hurdles.

2. Growth Drivers for the Next Decade
Future sales growth hinges on several factors:

• Market Expansion: Increasing awareness and approvals in emerging markets.
• New Indications: Investment in clinical trials for pediatric SBS, inflammatory bowel disease, and broader gastrointestinal disorders.
• Pipeline Progress: Introducing next-generation analogs with improved pharmacokinetics and safety profile.
• Price Optimization: Strategic negotiations and value-based pricing models.

3. Revenue Projections and Market Penetration
Analysts project that, with a compound annual growth rate (CAGR) of roughly 6-8%, global sales could reach $400-$600 million by 2030. This trajectory is contingent on successful pipeline development, competitive pricing, and broader healthcare system acceptance.

4. Cost and Profitability Considerations
The high manufacturing complexity and patent lifecycle influence profit margins. Assuming price stabilization and market expansion, profit margins could improve through operational efficiencies and healthcare payer negotiations.

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Emerging Opportunities and Strategic Outlook

1. Clinical Innovation and Combination Therapies
Combining teduglutide with other regenerative agents or microbiome-targeted therapies may enhance efficacy, broadening indications and increasing patient responsiveness.

2. Biosimilar Competition and Patent Strategies
Proactive patent management and lifecycle extension initiatives are critical to sustain market exclusivity. Partnering or licensing deals with biosimilar manufacturers could mitigate patent expiration risks.

3. Digital and Remote Monitoring Technologies
Integration of digital health platforms for adherence and efficacy monitoring can improve patient outcomes and reduce invasive management costs, supporting wider adoption.

4. Global Market Penetration
Expanding into Middle Eastern, Asian, and Latin American markets, where SBS diagnosis is increasing, can unlock new revenue streams, provided regulatory and reimbursement pathways are navigated effectively.

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Key Takeaways

• Niche yet Growing: Teduglutide remains a specialized therapy for SBS, with steady growth driven by expanding indications and geographic markets.
• Financial Stability With Revenue Potential: Current revenues are robust, but growth opportunities depend on pipeline advances, market access, and comparator therapies.
• Pricing and Reimbursement are Critical: Achieving optimal reimbursement strategies will sustain profitability amid high manufacturing costs and emerging biosimilars.
• Pipeline and Innovation are Key: Future success hinges on developing next-generation analogs and exploring new indications, including pediatric and inflammatory bowel diseases.
• Market Expansion Is Essential: Targeting emerging markets and integrating digital health tools can unlock additional growth corridors.

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FAQs

1. What are the main indications for teduglutide?
Teduglutide is primarily indicated for adults with short bowel syndrome dependent on parenteral nutrition. Its approval has expanded to include pediatric SBS patients and is under investigation for other gastrointestinal conditions.

2. How does teduglutide compare to emerging therapies?
While currently the only approved GLP-2 analog, newer formulations like apraglutide aim to improve dosing frequency and safety profiles, potentially challenging teduglutide’s market position over time.

3. What factors influence the pricing and reimbursement of teduglutide?
High manufacturing costs, demonstrated clinical benefits, long-term cost savings from reduced PN dependence, and healthcare system reimbursement policies significantly impact pricing and access.

4. How is patent expiration impacting the market?
Patent expirations in the late 2020s could lead to biosimilar entry, increasing competition and potentially reducing prices unless strategic lifecycle management measures are implemented.

5. What is the outlook for TEDUGLUTIDE's future sales growth?
Forecasts suggest moderate to strong growth over the next decade, driven by market expansion, pipeline development, and healthcare system acceptance, with potential revenues reaching $400–600 million annually by 2030.

References

[1] Rousseau, M., et al. "Short bowel syndrome prevalence and management." Gastroenterology Today, 2020.
[2] Takeda Pharmaceuticals. “Annual Report 2021,” Takeda.