ELIGLUSTAT TARTRATE - Generic Drug Details

What are the generic drug sources for eliglustat tartrate and what is the scope of freedom to operate?

Eliglustat tartrate is the generic ingredient in two branded drugs marketed by Genzyme Corp, Aizant, Apotex, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs, and is included in six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eliglustat tartrate has one hundred and sixty-two patent family members in forty-four countries.

There are six drug master file entries for eliglustat tartrate. One supplier is listed for this compound.

Summary for ELIGLUSTAT TARTRATE

International Patents:	162
US Patents:	4
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	6
Patent Applications:	137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIGLUSTAT TARTRATE
DailyMed Link:	ELIGLUSTAT TARTRATE at DailyMed

Recent Clinical Trials for ELIGLUSTAT TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sanofi	Phase 1
Genzyme, a Sanofi Company	Phase 1
Genzyme, a Sanofi Company	Phase 3

See all ELIGLUSTAT TARTRATE clinical trials

Pharmacology for ELIGLUSTAT TARTRATE

Drug Class	Glucosylceramide Synthase Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ELIGLUSTAT TARTRATE

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 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
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	7,196,205			Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,547
Aizant	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212463-001	Sep 8, 2021	AB	RX	No	No
Dr Reddys	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212449-001	Aug 17, 2022		DISCN	No	No
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,544
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	11,458,119		Y	Y

Expired US Patents for ELIGLUSTAT TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	6,916,802
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	7,615,573
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	7,253,185

International Patents for ELIGLUSTAT TARTRATE

Country	Patent Number	Title	Estimated Expiration
Poland	3133070
Denmark	2067775
Japan	2010095546	SYNTHESIS OF UDP-GLUCOSE: N-ACYLSPHINGOSINE GLUCOSYLTRANSFERASE INHIBITOR
Russian Federation	2020119588	СПОСОБЫ ЛЕЧЕНИЯ БОЛЕЗНИ ГОШЕ
Spain	2395463
Slovenia	2796457

Supplementary Protection Certificates for ELIGLUSTAT TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1409467	C20150027 00161	Estonia		PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
1409467	1590029-3	Sweden		PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
1409467	C300738	Netherlands		PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	37/2015	Austria		PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	2015/027	Ireland		PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	132016000023075	Italy		PRODUCT NAME: ELIGLUSTAT, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACOLOGICAMENTE ACCETTABILE(CERDELGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/974, 20150119

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]