TEDUGLUTIDE - Generic Drug Details

What are the generic drug sources for teduglutide and what is the scope of freedom to operate?

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	7,847,061*PED				Y
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

International Patents for TEDUGLUTIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2008518941
Canada	2585482	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	5197012
World Intellectual Property Organization (WIPO)	2006050244
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)
Spain	2427150

Supplementary Protection Certificates for TEDUGLUTIDE

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

Market Dynamics and Financial Trajectory for TEDUGLUTIDE

Last updated: February 16, 2026

Current Market Status

Teduglutide, marketed as Gattex in the U.S. and Revestive in Europe, is a recombinant human glucagon-like peptide-2 (GLP-2) analog approved for treating short bowel syndrome (SBS). Since its approval by the U.S. Food and Drug Administration (FDA) in August 2012, it has secured a niche market among orphan drugs for SBS, a rare condition characterized by malabsorption due to extensive bowel resection.

The global SBS treatment market, estimated at approximately $600 million in 2022, is projected to grow at a compounded annual growth rate (CAGR) of around 8% through 2027, driven by increasing diagnosis rates and off-label uses.

Market Drivers

• Orphan Drug Incentives: Regulatory exclusivity, tax credits, and expedited review pathways have incentivized the development and commercialization of therapies like TEDUGLUTIDE.

• Unmet Clinical Need: Limited effective treatments exist for SBS. TEDUGLUTIDE reduces dependence on parenteral nutrition, improving patient quality of life.

• Accreditation and Physician Adoption: Growing recognition by clinicians citing improved outcomes promotes expansion into new markets.

Market Challenges

• Market Penetration: Limited to specialized centers; reimbursement issues hinder wider adoption.

• Pricing and Cost: High treatment costs (~$250,000–$350,000 annually) restrict access and reimbursability.

• Alternative Therapies: Nutrition support and emerging therapeutic candidates aim to fill unmet needs, potentially influencing market share.

Revenue and Sales Trajectory

• Historical Data: The drug's U.S. net sales stood at approximately $23 million in 2018, which increased to roughly $78 million in 2021, reflecting steady growth.

• Forecast (2023–2027): Sales are projected to reach between $150 million and $200 million globally by 2027—assuming successful market expansion and increased utilization.

Market Expansion Strategies

• Label Expansion and Additional Indications: Clinical trials for indications such as Crohn's disease and ulcerative colitis aim to diversify revenue streams.

• Global Launches: Key markets like Japan, Canada, and emerging economies are targeted for regulatory approvals to broaden access.

• Pricing Negotiation and Reimbursement: Collaborations with payers to optimize reimbursement are critical for growth.

Competitive Landscape

• Current Competitors: Limited direct alternatives; however, other options include nutritional management strategies and emerging biologics targeting intestinal growth factors.

• Potential Entrants: Biotech companies developing novel GLP-2 analogs or combination therapies could alter the competitive environment.

Financial Outlook

• R&D Investment: Continued investment is necessary for regulatory filings, especially for new indications and formulations.

• Profitability: As sales increase, economies of scale can improve margins. Current margins are limited by high manufacturing costs and payer negotiations.

• Partnerships & Licensing: Strategic deals with global firms could accelerate market penetration.

Key Factors Influencing Future Performance

• Regulatory approvals for additional indications could significantly expand market size.
• Pricing negotiations with payers will directly impact revenue potential.
• Innovation in formulation or delivery methods could improve adherence and efficacy.
• Competitive products could pressure market share if they demonstrate superior efficacy or cost-effectiveness.

References

1. IQVIA. “Global Short Bowel Syndrome Market Report.” 2022.
2. FDA. “FDA Approves Gattex for Short Bowel Syndrome.” 2012.
3. EvaluatePharma. "Pharma Market Analysis," 2022.
4. Research and Markets. “Global SBS Treatment Market Forecast,” 2023.
5. Bloomberg Intelligence. “Biotech Market Trends,” 2022.

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Key Takeaways

• TEDUGLUTIDE has carved a niche through orphan drug status, with global sales projected to double by 2027.
• Market expansion hinges on regulatory success, reimbursement strategies, and clinical adoption.
• Limited direct competition exists, but emerging therapies could challenge its market position.
• Continuous innovation and strategic partnerships are essential for sustaining growth.

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Frequently Asked Questions

1. What is the primary medical use of TEDUGLUTIDE?
It is approved for reducing dependence on parenteral nutrition in adult patients with short bowel syndrome.

2. How has the sales trend evolved since its approval?
Sales have grown from approximately $23 million in 2018 to about $78 million in 2021, with projections reaching $150–200 million nationally by 2027.

3. What are the main barriers to market expansion for TEDUGLUTIDE?
Reimbursement issues, high treatment costs, limited clinical adoption, and regulatory approval barriers in new markets.

4. Are there any significant competitors to TEDUGLUTIDE?
Currently, no direct rivals; however, nutritional therapies and emerging biologics targeting similar patient populations pose potential competition.

5. What growth opportunities exist beyond SBS?
Potential expansion into Crohn's disease, ulcerative colitis, and other intestinal disorders based on ongoing clinical trials and label expansion efforts.

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Citations

[1] IQVIA, 2022. "Global Short Bowel Syndrome Market Report."
[2] FDA, 2012. "FDA Approves Gattex for Short Bowel Syndrome."
[3] EvaluatePharma, 2022. "Pharma Market Analysis."
[4] Research and Markets, 2023. "Global SBS Treatment Market Forecast."
[5] Bloomberg Intelligence, 2022. "Biotech Market Trends."