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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 five 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:	12
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
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3
Allegheny Singer Research Institute	Phase 3
Takeda	Phase 2

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
Japan	2008518941
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	4149497
World Intellectual Property Organization (WIPO)	9632414
Hong Kong	1147761

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	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

GATTEX KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of GATTEX (Teduglutide)

Introduction to GATTEX

GATTEX, also known as teduglutide, is a groundbreaking therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. This drug has significantly impacted the market dynamics and financial trajectory of the SBS treatment sector.

Approval and Regulatory Landscape

GATTEX was approved by the FDA in December 2012 for subcutaneous use in adult patients with SBS. It received orphan drug designation from both the FDA and the European Medicines Agency (EMA), highlighting its importance in treating a rare and debilitating condition[3].

Market Drivers

Growing Prescriptions

The increasing prescriptions of GATTEX in the U.S. and its European counterpart, Revestive, have been a major driver of the SBS market growth. These drugs have shown significant efficacy in reducing the need for parenteral nutrition (PN) and intravenous (IV) support, improving the quality of life for SBS patients[1].

Clinical Efficacy

Clinical trials, such as the STEPS and STEPS-2 studies, have demonstrated the effectiveness of GATTEX. For instance, in the STEPS trial, 63% of patients treated with GATTEX achieved a 20% or greater reduction in weekly PN/IV volume compared to 30% for the placebo group. This clinical success has bolstered the drug's market position[3][5].

Reimbursement and Access

Efficient reimbursement scenarios in North America and Europe have further boosted the market for GATTEX. NPS Pharmaceuticals, the original developer, and later Takeda, after acquiring NPS, have worked closely with payers to ensure access to this critical therapy. Programs like NPS Advantage have helped patients navigate the reimbursement landscape, enhancing the drug's adoption[3].

Financial Performance

Revenue Growth

The approval and subsequent launch of GATTEX have contributed significantly to the revenue growth of the companies involved. For example, NPS Pharmaceuticals' acquisition by Shire (now part of Takeda) was partly driven by the potential of GATTEX. Shire's strong revenue growth, including a 9% increase in product sales in 2015, was partly attributed to the performance of GATTEX and other acquired products[2].

Market Share

Takeda Pharmaceutical Company, which acquired Shire and thus the rights to GATTEX, holds the largest market share in the SBS market. The company's robust R&D investments and strategic acquisitions have solidified its position, with GATTEX being a key contributor to its market dominance[4].

Competitive Landscape

Key Players

The SBS market is competitive, with several pharmaceutical giants operating in the space. Besides Takeda, other notable players include Merck KGaA, Emmaus Life Sciences, Inc., Nutrinia Ltd, GlyPharma Therapeutics, OxThera, and Ardelyx, Inc. However, Takeda's strong focus on R&D and its extensive pipeline have kept it at the forefront[1][4].

Market Segmentation and Growth

GLP-2 Segment Dominance

The GLP-2 segment, which includes GATTEX, dominates the SBS market due to the presence of approved products and a robust pipeline. The increasing penetration of GLP-2 drugs among SBS patients and awareness programs by various organizations are expected to drive market growth[4].

Regional Growth

North America, particularly the U.S., holds the largest market share for SBS treatments, driven by the high adoption of GATTEX. Europe follows closely, with Revestive being the highest-grossing drug in the region. The Asia Pacific region is expected to register the highest CAGR during the forecast period due to rising awareness and R&D investments[1][4].

Challenges and Limitations

Cost and Reimbursement

Despite its efficacy, GATTEX is considered expensive, which limits its adoption in some regions. The lack of reimbursement policies in countries like India and Africa further hampers market growth. However, the growing number of online and retail pharmacies, especially in the U.S. and Europe, is helping to mitigate some of these challenges[4].

Future Outlook

Market Projections

The global SBS market, driven by drugs like GATTEX, is projected to grow from $1.42 billion in 2024 to $2.60 billion by 2032, at a CAGR of 7.9%. The increasing demand for GLP-2 drugs and the expanding distribution networks of major players are expected to fuel this growth[4].

Pipeline and R&D

Takeda and other key players continue to invest heavily in R&D, focusing on developing new drugs and biologics for SBS. This ongoing innovation is expected to further enhance the market's growth trajectory and provide more treatment options for patients[2][4].

Key Takeaways

• Approval and Efficacy: GATTEX was approved by the FDA in 2012 and has shown significant clinical efficacy in reducing PN/IV volume.
• Market Drivers: Growing prescriptions, efficient reimbursement, and strong clinical performance are key drivers.
• Financial Performance: The drug has contributed to the revenue growth of companies like NPS Pharmaceuticals and Takeda.
• Competitive Landscape: Takeda holds the largest market share, with a strong focus on R&D and strategic acquisitions.
• Market Segmentation: The GLP-2 segment dominates, with North America and Europe being the largest markets.
• Challenges: High cost and limited reimbursement policies in some regions are significant challenges.
• Future Outlook: The market is projected to grow significantly, driven by increasing demand for GLP-2 drugs and expanding distribution networks.

FAQs

What is GATTEX used for?

GATTEX (teduglutide) is used for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support.

Who approved GATTEX?

GATTEX was approved by the U.S. Food and Drug Administration (FDA) in December 2012.

What are the key clinical findings of GATTEX?

In clinical trials, GATTEX has shown that 63% of patients achieved a 20% or greater reduction in weekly PN/IV volume, and 54% reduced the number of infusion days per week by one or more days[3][5].

Which company holds the largest market share for GATTEX?

Takeda Pharmaceutical Company holds the largest market share for GATTEX, following its acquisition of Shire and NPS Pharmaceuticals[4].

What are the challenges facing the adoption of GATTEX?

High cost and limited reimbursement policies in some regions are significant challenges to the adoption of GATTEX[4].

What is the projected market growth for SBS treatments like GATTEX?

The global SBS market is projected to grow from $1.42 billion in 2024 to $2.60 billion by 2032, at a CAGR of 7.9%[4].

Sources

1. Global Short Bowel Syndrome Market, 2017 to 2025: Growing Prescriptions of Gattex and Revestive in U.S. and Europe Respectively is Boosting the Growth of the Market. Globenewswire.
2. Shire delivers strong revenue growth and cash generation. Takeda.
3. FDA Approves Gattex® (teduglutide [rDNA Origin]) for Injection for the Treatment of Adult Short Bowel Syndrome. PR Newswire.
4. Short Bowel Syndrome Market Size, Share, Growth Report, 2032. Fortune Business Insights.
5. GATTEX® (teduglutide) Results in Adults With Short Bowel Syndrome. Gattex.com.