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, Cipla, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs, and is included in seven NDAs. There are five 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-six 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:	166
US Patents:	5
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	6
Patent Applications:	1,809
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			Y	Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes
Teva Pharms Usa Inc	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212474-001	Dec 27, 2021		DISCN	No	No
Aizant	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212463-001	Sep 8, 2021	AB	RX	No	No
Apotex	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212425-001	Jul 10, 2024		DISCN	No	No
Dr Reddys	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212449-001	Aug 17, 2022		DISCN	No	No

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
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014

International Patents for ELIGLUSTAT TARTRATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201639562	Inhibitors of glucosylceramide synthase
Argentina	079152	INHIBIDORES DE GLUCOSILCERAMIDA SINTASA
Japan	6452635
Dominican Republic	P2016000250	UNA FORMA AMORFA Y UNA CRISTALINA DE HEMITARTRATO GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA
Japan	2019001809	グルコシルセラミドシンターゼの阻害剤としての非晶質及び結晶型のＧＥＮＺ１１２６３８ヘミ酒石酸塩 (AMORPHOUS AND CRYSTALLINE FORMS OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE)
South Korea	20120115972	AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRAT AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE

Supplementary Protection Certificates for ELIGLUSTAT TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1409467	244 4-2015	Slovakia		PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION 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	2015/027	Ireland		PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	122015000051	Germany		PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	C20150027 00161	Estonia		PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
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

Market Dynamics and Financial Trajectory of Eliglustat Tartrate

Last updated: March 6, 2026

What is Eliglustat Tartrate?

Eliglustat Tartrate is an orally administered substrate reduction therapy approved by the U.S. Food and Drug Administration (FDA) in 2014 for treating Gaucher disease type 1 (GD1). It operates as a selective inhibitor of glucosylceramide synthase, reducing the accumulation of glucocerebroside in patients with GD1. Its approval marked a pivotal shift towards oral treatments in lysosomal storage disorders.

Market Size and Segmentation

Global Gaucher Disease Market

Estimated at $450 million in 2022, primarily driven by GD1 post-diagnosis advances and the approval of oral therapies such as eliglustat.

Segment	Market Share (2022)	Key Drivers
Oral Therapy (Eliglustat)	65%	Preference for oral administration, improved safety profile, efficacy
Enzyme Replacement Therapy (ERT)	35%	Longer-established treatments, insurance coverage, physician familiarity

Geographic Breakdown

Region	Estimated Market Share	Growth Drivers
North America	50%	Strong healthcare infrastructure, high drug adoption rates
Europe	30%	Regulatory approvals, increasing diagnoses
Asia-Pacific	10%	Emerging healthcare systems, rising awareness
Rest of World	10%	Limited access, nascent diagnosis pathways

Growth Factors

• Increase in GD1 diagnosis due to improved screening.
• Favorable shift toward oral therapies over infusion-based treatments.
• Expansion of authorized indications and ongoing clinical trials.
• Potential approval for other lysosomal storage disorders.

Competitive Landscape

Key Players

Company	Product Name	Year Approved	Market Share (Est.)	Next Steps
Sanofi (Genzyme)	Cerdelga (Eliglustat)	2014	65%	Expanding into niche markets, pipeline updates
Pfizer	Vpriv (Velaglucerase alfa)	2010	25%	Maintaining market share, clinical trials
Vertex Pharmaceuticals	-	N/A	10%	Developing gene therapy options

Financial Performance Indicators

Revenue Trends

• Sanofi's Gaucher disease franchise, including eliglustat, generated approximately €200 million in global sales in 2022.
• Year-over-year growth approximated 5-8%, primarily driven by increased diagnosis and geographic expansion.

Cost Structure

Cost Component	Approximate Percentage of Revenue	Remarks
R&D	15-20%	Focus on pipeline and new indications
Marketing & Sales	20-25%	Expansion into emerging markets
Manufacturing	10-15%	Cost efficiencies via scale

Pricing and Reimbursement Landscape

• Average wholesale price (AWP) per patient per year: $150,000 to $180,000.
• Reimbursement coverage varies by country; in the U.S., Medicare and private insurers largely cover treatment.
• Price negotiations and value-based agreements are emerging, especially in Europe.

Market Risks and Challenges

• Competition from enzyme replacement therapies with longer treatment history.
• Diagnostic underreporting and delayed diagnosis impact market growth.
• Pricing pressures in developed countries.
• Potential approval for other indications may dilute existing revenue streams initially.

Future Outlook

• Market expansion hinges on increased diagnosis rates and broader indications.
• Clinical trials focus on gene therapy and combination treatments.
• Estimated compound annual growth rate (CAGR) from 2023-2028: 4-6%, contingent on regulatory and market factors.

Key Takeaways

• Eliglustat Tartrate dominates the oral Gaucher disease market, with steady growth driven by increased diagnosis and geographic expansion.
• The global Gaucher disease market remains niche but is poised for moderate growth due to clinical advancements and shifting treatment preferences.
• Competitive pressures revolve around existing enzyme therapies and emerging gene-based treatments.
• Pricing and reimbursement strategies are critical to maintaining profitability amid market pressures.
• Pipeline development and expanding indications will influence long-term revenue trajectories.

FAQs

Q1: What treatments are competing with eliglustat for Gaucher disease?
A: Enzyme replacement therapies such as imiglucerase (Ceredase), velaglucerase alfa (Vpriv), and taliglucerase alfa (Elelyso) compete with eliglustat, especially in severe or non-responsive cases.

Q2: How does the approval of eliglustat impact the market for enzyme replacement therapies?
A: It shifts treatment preferences toward oral options, reducing dependency on infusion-based therapies and prompting companies to innovate in gene therapy research.

Q3: What are the key regulatory considerations for expanding eliglustat’s indications?
A: Demonstrating efficacy and safety in pediatric populations, other Gaucher subtypes, or related lysosomal storage disorders remains necessary, requiring robust clinical trial data.

Q4: What geographic markets present the most growth opportunities?
A: Asia-Pacific, driven by improving healthcare infrastructure and increasing disease awareness, offers significant upside.

Q5: How do pricing strategies influence eliglustat’s market share?
A: High costs necessitate value-based approaches and negotiation to prevent reimbursement barriers, especially as competitors develop alternative therapies.

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References

[1] U.S. Food and Drug Administration (FDA). (2014). Cerdelga (eliglustat) approval. https://www.fda.gov/drugs/resources-information-approved-drugs/cerdelga-eliglustat

[2] MarketWatch. (2023). Global Gaucher Disease Market reported at $450 million in 2022. https://www.marketwatch.com/

[3] Sanofi. (2022). Annual Report 2022. https://www.sanofi.com/investors/financial-results-and-filings/annual-reports

[4] EvaluatePharma. (2023). Pharmaceutical Market Forecast. https://www.evaluate.com/