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:	35
Patent Applications:	618
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
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3
Allegheny Singer Research Institute	Phase 3
Takeda Development Center Americas, Inc.	Phase 1

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					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 TEDUGLUTIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2427150
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)
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)
Denmark	1809318
Hong Kong	1107026	TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY
Japan	5197012

Supplementary Protection Certificates for TEDUGLUTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0906338	92153	Luxembourg		PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338	2013/006	Ireland		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	13C0013	France		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830

TEDUGLUTIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Teduglutide

Introduction

Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, has been a significant player in the treatment of short bowel syndrome (SBS) and other intestinal disorders. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key factors driving its growth and challenges it faces.

Market Size and Growth Projections

The teduglutide market has been experiencing robust growth. As of 2023, the market size was valued at USD 50 billion and is projected to reach USD 97.4 billion by 2031, growing at a compound annual growth rate (CAGR) of 10% from 2024 to 2031[1][3].

Key Drivers of Market Growth

Several factors are driving the growth of the teduglutide market:

Increasing Prevalence of Short Bowel Syndrome

The rising prevalence of SBS and other intestinal failures is a major driver. As more patients are diagnosed, the demand for effective treatments like teduglutide increases[1][3].

Advancements in Medication Delivery Technologies

Improvements in drug delivery systems, such as injections, vials, lyophilized powder, prefilled syringes, and cartridges, have enhanced patient compliance and treatment efficacy[1].

Regulatory Frameworks

Favorable regulatory environments and government programs that fund therapies for rare diseases have supported the market's expansion. Reimbursement policies also play a crucial role in making teduglutide more accessible[1].

Strategic Alliances and Collaborations

Pharmaceutical companies are forming strategic alliances to improve the distribution and accessibility of teduglutide, further boosting its market penetration[1].

Market Segmentation

The teduglutide market is segmented based on application, product type, and geographical regions.

Application Segments

• Injections
• Vials
• Lyophilized Powder
• Prefilled Syringes
• Cartridges[1]

Product Segments

• Short Bowel Syndrome
• Parenteral Nutrition
• Pediatric Short Bowel Syndrome
• Intestinal Failure
• Chronic Intestinal Pseudo-obstruction[1]

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1][3]

Cost-Effectiveness and Economic Considerations

Despite its efficacy, teduglutide faces significant economic hurdles. A study on the cost-effectiveness of teduglutide in adult patients with SBS revealed that the treatment costs $949,910 per quality-adjusted life year (QALY) gained. For it to be considered cost-effective, the cost would need to be reduced by more than 65% to reach the typical threshold of $100,000/QALY[2].

Competitive Landscape

The competitive landscape of the teduglutide market is characterized by a few key players, with Takeda Pharmaceuticals being a major player due to its product Gattex (teduglutide). The market report includes detailed profiles of these companies, their market entry years, and various market-related factors[1].

Patent and Generic Entry

The patents protecting Gattex are set to expire on May 16, 2026, which could lead to generic entry and potentially alter the market dynamics. However, patent challenges or generic licensing could change this timeline[5].

Regional Analysis

The market is expected to be dominated by North America and Europe, driven by advanced healthcare infrastructure and higher awareness of SBS treatments. However, the Asia-Pacific region is also anticipated to show significant growth due to increasing healthcare investments and growing awareness campaigns[1][3].

Challenges and Restraints

Despite the positive outlook, the teduglutide market faces several challenges:

High Cost

The high cost of teduglutide treatment remains a significant barrier to widespread adoption. Reducing the cost is crucial for making the treatment more accessible and cost-effective[2].

Regulatory Hurdles

While favorable regulatory frameworks support the market, any changes in these regulations could impact the market's growth trajectory[1].

Competition from Alternatives

The market may face competition from alternative treatments and therapies that could emerge during the forecast period[1].

Market Trends and Opportunities

Several trends and opportunities are shaping the future of the teduglutide market:

Technological Advancements

Advancements in biotechnology and pharmaceutical research are leading to better formulations of teduglutide, enhancing its effectiveness and patient compliance[1].

Increasing Investment in Healthcare Infrastructure

Growing investments in healthcare infrastructure, particularly in emerging markets, are expected to drive the demand for teduglutide and other specialized treatments[1].

Awareness Campaigns

Increased awareness campaigns about SBS and the availability of effective treatments like teduglutide are improving patient outcomes and driving market growth[1].

Key Takeaways

• The teduglutide market is projected to grow significantly, reaching USD 97.4 billion by 2031.
• The market is driven by the increasing prevalence of SBS, advancements in medication delivery technologies, and favorable regulatory frameworks.
• High costs remain a significant challenge, and reducing these costs is essential for broader adoption.
• The market is segmented by application, product type, and geographical regions.
• Patent expirations and potential generic entries could impact market dynamics.

FAQs

1. What is the projected market size of teduglutide by 2031? The teduglutide market is expected to reach USD 97.4 billion by 2031[1].

2. What are the main drivers of the teduglutide market growth? The main drivers include the increasing prevalence of SBS, advancements in medication delivery technologies, favorable regulatory frameworks, and strategic alliances among pharmaceutical companies[1].

3. How cost-effective is teduglutide treatment? Teduglutide treatment is not cost-effective at current prices, costing $949,910 per QALY gained. It would need a cost reduction of more than 65% to be considered cost-effective[2].

4. When are the patents protecting Gattex (teduglutide) set to expire? The patents protecting Gattex are set to expire on May 16, 2026[5].

5. Which regions are expected to dominate the teduglutide market? North America and Europe are expected to dominate the market, with the Asia-Pacific region also showing significant growth potential[1][3].

Sources

1. Market Research Intellect - Teduglutide Market Size, Share | Industry Research Report 2031
2. PubMed - Cost-effectiveness of teduglutide in adult patients with short bowel syndrome
3. Market Research Intellect - Teduglutide Drugs Sales Market Size, Scope And Forecast Report
4. Cognitive Market Research - Teduglutide Market Report 2024 (Global Edition)
5. DrugPatentWatch - When will the patents on GATTEX KIT expire?