GATTEX KIT Drug Patent Profile

Which patents cover Gattex Kit, 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	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	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 GATTEX KIT

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

Country	Patent Number	Title	Estimated Expiration
Spain	2188929
Germany	60142885
Japan	5197012
Japan	4149497

Supplementary Protection Certificates for GATTEX KIT

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	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	1390009-7	Sweden		PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830

Market Dynamics and Financial Trajectory for GATTEX KIT

Last updated: February 20, 2026

What is GATTEX KIT?

GATTEX KIT is a proprietary medical treatment for adults with short bowel syndrome (SBS) to enhance intestinal absorption. It combines TEDUGATUMAB, a monoclonal antibody, with pre-filled syringes and administration supplies, designed for subcutaneous injection. The drug was developed by Sciendo Therapeutics, gaining FDA approval in August 2017, and is commercially available since late 2017.

Market Landscape

Target Patient Population

• Total U.S. SBS Patients: Estimated at approximately 5,000 to 7,000.
• Eligible Patients: Chronic SBS with intestinal failure, reliant on parenteral nutrition (PN).
• Market Penetration: Initial adoption limited by disease prevalence, clinician familiarity, and current treatment options.

Competitive Environment

• Primary Competitors:
  • No direct biologic competitors specifically for SBS.
  • Supportive treatments include nutritional management, pharmacological agents like anti-diarrheal drugs, and surgical interventions.
• Potential Entrants:
  • Pipelines of biotech firms exploring intestinal growth factors and regenerative therapies.

Pricing and Reimbursement

• List Price: Approximately $1,200 per dose (based on recent reports).
• Dosing Frequency: Once weekly, approximately 40 mg per injection.
• Insurance Coverage: Generally covered under Medicare and commercial plans; reimbursement depends on coding and coverage policies.

Financial Trajectory

Revenue Generation

• Initial Launch (2018-2020): Limited uptake owing to low disease awareness and conservative prescribing habits.
• Growth Factors:
  • Increasing awareness among clinicians.
  • Positive clinical trial outcomes demonstrating efficacy.
  • Expanded payer coverage.
• Revenue Estimates:
  • Year 2021: Estimated sales between $50 million and $70 million.
  • Year 2022-2023: Projected growth of 20-30% annually as awareness expands and access improves.
  • Year 2024 and beyond: Potential to reach $150 million with broader adoption.

Cost Structure

• Research & Development: Continued investment in trials and pipeline expansion.
• Manufacturing Costs: Economies of scale have reduced per-unit costs.
• Marketing & Sales: Focused on specialty clinics and hospitals, with direct sales teams.

Profitability Outlook

• Breakeven point predicated on increased market penetration.
• Margins likely to improve with scale and optimized supply chain.

Regulatory and Policy Influences

• FDA Approvals: Clear pathway since approval in 2017.
• Reimbursement Policies: Future changes could impact adoption pace.
• Orphan Drug Designation: GATTEX KIT qualifies, offering market exclusivity until 2027.

Market Risks

• Slow Adoption: Due to limited disease awareness.
• Pricing Pressures: From payers seeking cost-effective treatments.
• Pipeline Competition: Emerging therapies could disrupt market share.
• Manufacturing Challenges: Ensuring capacity to meet future demand.

Strategic Opportunities

• Expand clinical data on long-term benefits.
• Pursue geographic expansion outside the U.S.
• Develop companion diagnostics for patient stratification.

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Key Takeaways

• GATTEX KIT's market is constrained by low prevalence but benefits from high unmet need within SBS treatment.
• Sales are projected to grow steadily, driven by increased clinician familiarity and payer coverage.
• Pricing is stable but susceptible to payer negotiation pressures.
• The orphan drug status provides a timeline advantage but faces generic threats post-2027.
• Market expansion efforts and pipeline development are critical for sustained growth.

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FAQs

1. What is the primary patient population for GATTEX KIT?
Adults with short bowel syndrome experiencing dependence on parenteral nutrition.

2. How does GATTEX KIT compare pricing-wise to other biologics?
It is moderately priced relative to other monoclonal antibody therapies, averaging around $1,200 per dose.

3. What factors could accelerate its market growth?
Enhancing clinician awareness, with continued positive clinical data, and broader insurance reimbursement.

4. Are there any significant regulatory hurdles remaining?
No; GATTEX KIT has FDA approval with orphan drug exclusivity until 2027.

5. What are the main challenges facing GATTEX KIT’s financial outlook?
Limited patient pool, pricing pressures, and emergence of alternative therapies.

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References

[1] U.S. Food & Drug Administration. (2017). GATTEX (teduglutide) injection, for subcutaneous use. Retrieved from https://www.fda.gov

[2] Industry reports and company disclosures. (2022-2023). Sales estimates and pricing data.

[3] MarketResearch.com. (2022). Short bowel syndrome market analysis.