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
Napo Pharmaceuticals, Inc.	EARLY_PHASE1
Lindsey Russell, MD	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					Y
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes					Y

International Patents for TEDUGLUTIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	1809318
Japan	2008518941
Japan	5197012
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)
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)

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	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
0906338	2013/006	Ireland		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830

Market Dynamics and Financial Trajectory for TEDUGLUTIDE

Last updated: April 8, 2026

What is the current market landscape for TEDUGLUTIDE?

TEDUGLUTIDE is a recombinant analog of adrenomedullin, marketed primarily for the treatment of adult patients with short bowel syndrome (SBS) who depend on parenteral support. As of 2023, TEDUGLUTIDE operates in a niche segment within the gastrointestinal metabolism space, with limited competition and growing recognition of its clinical benefits.

Key Market Players:

• EnteraBio (developing biosimilars)
• Takeda Pharmaceutical (producer of TEDUGLUTIDE, marketed as Gattex and Revestive)

Regulatory Status:

• Approved in the U.S. (FDA, 2012)
• Approved in the EU (EMA, 2014)
• Additional approvals in Japan and other territories, expanding geographical reach.

Market Penetration:

• Estimated 15,000 to 20,000 eligible SBS patients globally.
• Approximate U.S. prescriptions: 600-1,200 annually, reflecting limited market penetration but with room for growth.

What are the key drivers and barriers impacting TEDUGLUTIDE market growth?

Drivers	Barriers
Increasing prevalence of SBS, especially post-surgical cases in aging populations	High treatment cost (~$130,000/year per patient in the U.S.)
Unmet medical need for growth-promoting therapy in SBS	Limited awareness among healthcare providers
Wait for potential expansion of indications (e.g., severe short bowel or Crohn’s disease)	Development of alternative therapeutics or biosimilars
Clinical data supporting long-term benefit and safety	Limited commercial coverage and reimbursement in some regions

Market Drivers:

• The rise in SBS incidence due to surgeries for cancer, trauma, or congenital disorders.
• Demonstrated reductions in parenteral nutrition dependence with TEDUGLUTIDE.
• Pattern of increasing prescription volume in existing markets as prescribers gain experience.

Market Barriers:

• Price sensitivity in healthcare systems limits access.
• Off-label use remains low; strict indication narrows market size.
• Biosimilar competition could erode brand share post-patent expiration (expected around 2024-2025).

How does the financial trajectory look for TEDUGLUTIDE?

Revenue Estimates:

• Takeda reported global sales of approximately $150 million in 2022.
• U.S. sales account for roughly 65-70% of revenue, given higher SBS prevalence and insurance coverage.

Growth Projections:

• Compound annual growth rate (CAGR) forecast: 4-6% over the next five years, driven by geographic expansion and increased prescriber adoption.
• Potential new indications, like Crohn’s disease or other malabsorptive conditions, could expand the market by an estimated additional 30-50%.

Year	Estimated Global Revenue (USD millions)	Growth Rate
2022	150	N/A
2023	155-160	3-6%
2024	165-170	3-6%
2025	175-180	4-6%

Pricing Strategy Effect:

• The high cost of therapy necessitates strong reimbursement strategies to sustain growth.
• Price reductions via biosimilar entrants are expected after patent expiry, potentially lowering prices by 40-60%.

Market Risks:

• If biosimilar versions gain rapid approval, market share could shift quickly.
• Evolving healthcare policies favoring cost-effective treatments may constrain revenue.

What are the key milestones influencing the financial outlook?

• Patent expiration: Scheduled for 2024-2025, opening biosimilar pathways.
• Regulatory extensions: Pending approvals in China and emerging markets could boost revenues.
• Clinical trials: Upcoming phase 3 trials for combination therapies or expanded indications could generate future revenue streams.

How does biosimilar competition impact the market?

Biosimilars share the same amino acid sequence and efficacy profile but aim to reduce costs. In 2021, the first biosimilar for TEDUGLUTIDE received approval in Europe.

• Biosimilar entry could lead to a 50% reduction in price.
• Fragmented approval process across regions could delay or limit biosimilar market penetration in certain territories.

Final market outlook for 2023-2027

Metric	2023	2024	2025	2026	2027
Revenue (USD millions)	155-160	165-170	175-180	185-190	195-205
Market Penetration	60-70% of potential	70-80%	80-85%	85-90%	90-95%
Biosimilar Impact	Low initially	Moderate adoption	Increased competition	Market stabilization	Market share stabilization

Key Takeaways

• TEDUGLUTIDE maintains a niche but steadily growing market within SBS treatment.
• Revenue growth is driven by geographic expansion, prescriber acceptance, and regulatory approvals.
• Patent expiry around 2024-2025 will introduce biosimilar competition, lowering prices but potentially expanding the market.
• Heavy dependence on reimbursement policies and treatment costs are significant market obstacles.
• Future indications and combination therapies could diversify revenue streams.

FAQs

1. What annual revenue does TEDUGLUTIDE generate?
Approximately $150 million globally in 2022, with modest growth predicted to reach up to $200 million by 2027.

2. When will biosimilars for TEDUGLUTIDE enter the market?
Biosimilar approval is expected around 2024-2025, following patent expiration.

3. What factors could limit TEDUGLUTIDE’s market expansion?
High treatment costs, limited awareness, and competition from biosimilars or alternative therapies.

4. Are there any additional indications for TEDUGLUTIDE?
Current approval is for SBS; ongoing trials may enable expansion into Crohn’s disease and other malabsorptive conditions.

5. How does geographic regulation affect revenue prospects?
Regional approval variability impacts sales; Asian markets like China remain in developmental stages but could contribute significantly post-approval.

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References

[1] FDA. (2012). FDA approves Gattex for short bowel syndrome.
[2] EMA. (2014). Marketing authorization for Revestive.
[3] Takeda. (2022). Annual report 2022.
[4] GlobalData. (2023). Short bowel syndrome therapeutics market report.
[5] IQVIA. (2022). Biologic and biosimilar market analysis.