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Last Updated: December 24, 2024

Teduglutide - Generic Drug Details


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What are the generic drug sources for teduglutide and what is the scope of patent protection?

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

SponsorPhase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 3
Allegheny Singer Research InstitutePhase 3
Takeda Development Center Americas, Inc.Phase 1

See all teduglutide clinical trials

Pharmacology for teduglutide
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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Takeda Pharms Usa GATTEX KIT teduglutide POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Takeda Pharms Usa GATTEX KIT teduglutide POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for teduglutide

Country Patent Number Title Estimated Expiration
Spain 2427150 ⤷  Subscribe
Japan 2008518941 ⤷  Subscribe
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) ⤷  Subscribe
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) ⤷  Subscribe
Denmark 1809318 ⤷  Subscribe
Hong Kong 1107026 TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY ⤷  Subscribe
Japan 5197012 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for teduglutide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0906338 92153 Luxembourg ⤷  Subscribe PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338 2013/006 Ireland ⤷  Subscribe PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 C300578 Netherlands ⤷  Subscribe PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 13C0013 France ⤷  Subscribe PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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?

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