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Last Updated: December 23, 2024

ELIGLUSTAT TARTRATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Eliglustat Tartrate

A generic version of ELIGLUSTAT TARTRATE was approved as eliglustat tartrate by AIZANT on September 8th, 2021.

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Drug patent expirations by year for ELIGLUSTAT TARTRATE
Recent Clinical Trials for ELIGLUSTAT TARTRATE

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SponsorPhase
SanofiPhase 1
Genzyme, a Sanofi CompanyPhase 1
Genzyme, a Sanofi CompanyPhase 3

See all ELIGLUSTAT TARTRATE clinical trials

Paragraph IV (Patent) Challenges for ELIGLUSTAT TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CERDELGA Capsules eliglustat tartrate 84 mg 205494 6 2018-08-20

US Patents and Regulatory Information for ELIGLUSTAT TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aizant ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212463-001 Sep 8, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa Inc ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212474-001 Dec 27, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212425-001 Jul 10, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212449-001 Aug 17, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212420-001 May 2, 2023 AB RX No No ⤷  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

ELIGLUSTAT TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eliglustat Tartrate

Introduction

Eliglustat tartrate, marketed under the brand name Cerdelga, is a novel oral substrate reduction therapy (SRT) used in the treatment of type 1 Gaucher disease (GD1), a rare genetic lysosomal storage disorder. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global eliglustat tartrate market is experiencing significant growth, driven by increasing demand for effective treatments for GD1. The market size for eliglustat tartrate was substantial in 2023, with a projected compound annual growth rate (CAGR) that indicates continued expansion through 2031[4].

Segmentation

The eliglustat tartrate market is segmented based on product type, application, and geography.

Product Type

The market is primarily split into three types based on purity:

  • Min Purity Less Than 98%
  • Min Purity 98%-99%
  • Min Purity More Than 99% The segment with a purity of less than 98% accounted for a noticeable share of the global market and is expected to experience significant growth[4].

Application

The primary applications of eliglustat tartrate are:

  • Research
  • Pharmaceutical The research segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[4].

Geography

The market covers major regions including:

  • United States
  • Europe
  • China
  • Japan
  • India
  • Southeast Asia
  • Latin America
  • Middle East and Africa Each region presents unique market dynamics and growth opportunities[1].

Competitor Landscape

The eliglustat tartrate market is characterized by a competitive landscape involving several key players:

  • Biophore
  • Hangzhou Utanpharma Biology
  • Tecoland
  • Raks Pharma
  • Symbio Generrics
  • Cangzhou Enke Pharma Tech
  • Clearsynth
  • Dr. Reddy’s Laboratories
  • Pharmaffiliates

These companies are focusing on strategies to strengthen their product portfolios and expand their business globally[1][4].

Clinical Efficacy and Safety

Eliglustat tartrate has demonstrated promising clinical efficacy in phase II trials. The drug has shown significant improvements in hemoglobin levels, platelet count, and reductions in spleen and liver volumes in patients with GD1. The drug is well-tolerated, with most adverse events being mild and treatment-related[2].

Cost Savings and Budget Impact

Transitioning patients from intravenous enzyme replacement therapy (ERT) to oral eliglustat tartrate can result in meaningful cost savings for payers. A budget impact analysis showed that increasing the market share of eliglustat from 12% to 44% could result in annual savings of $1,526,710 and total savings of $4,580,130 over three years. This is particularly significant for patients switching from ERT administered in hospital outpatient settings[3].

Technological Innovations and Market Trends

Technological innovations and advancements are expected to further optimize the performance of eliglustat tartrate, enabling it to acquire a wider range of applications in the downstream market. Factors such as customer preference analysis, market dynamics (drivers, restraints, opportunities), new product releases, and the impact of COVID-19 are crucial for understanding the market's trajectory[1].

Financial Projections

The financial trajectory of eliglustat tartrate is positive, with the global market expected to grow significantly through 2031. The compound annual growth rate (CAGR) for the eliglustat tartrate API industry is projected to be substantial, driven by increasing demand and cost savings associated with its use[4].

Regional Analysis

The market is analyzed across various regions, each with its own set of dynamics and growth opportunities. For instance, the North American and European markets are expected to be significant contributors to the global market size, while emerging markets in Asia-Pacific and Latin America are also showing promising growth[1][4].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as regional conflicts, the impact of COVID-19, and the need for continuous technological innovation. However, these challenges also present opportunities for companies to adapt and innovate, thereby strengthening their market position[1].

Key Takeaways

  • Market Growth: The eliglustat tartrate market is expected to grow significantly through 2031, driven by increasing demand and technological innovations.
  • Cost Savings: Transitioning patients from ERT to eliglustat tartrate can result in substantial cost savings for payers.
  • Clinical Efficacy: Eliglustat tartrate has demonstrated strong clinical efficacy and safety in treating GD1.
  • Competitive Landscape: The market is competitive, with several key players focusing on expanding their product portfolios.
  • Regional Dynamics: Different regions present unique market opportunities and challenges.

FAQs

  1. What is eliglustat tartrate used for? Eliglustat tartrate is used for the treatment of type 1 Gaucher disease (GD1), a rare genetic lysosomal storage disorder.

  2. What are the primary applications of eliglustat tartrate? The primary applications are in research and pharmaceutical use.

  3. How does eliglustat tartrate compare to traditional ERT in terms of cost? Eliglustat tartrate can result in significant cost savings compared to traditional intravenous enzyme replacement therapy (ERT), especially when administered instead of hospital-based ERT[3].

  4. What are the key regions for the eliglustat tartrate market? The key regions include the United States, Europe, China, Japan, India, Southeast Asia, Latin America, and the Middle East and Africa[1].

  5. What is the expected growth rate of the eliglustat tartrate market? The market is expected to grow at a substantial compound annual growth rate (CAGR) through 2031[4].

Cited Sources

  1. Global Eliglustat Tartrate Market Research Report 2022 - Market Size, Current Insights and Development Trends[1]
  2. Phase II Data for Eliglustat Tartrate Demonstrates Efficacy - OncLive[2]
  3. Budget Impact Analysis of Eliglustat for the Treatment of Gaucher Disease - PubMed[3]
  4. Global Eliglustat Tartrate API Market Report 2024 - Cognitive Market Research[4]

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