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:	855
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
Genzyme, a Sanofi Company	Phase 1
Sanofi	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
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	12,465,586
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	11,458,119		Y	Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,547
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

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	7,615,573
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	7,253,185

International Patents for eliglustat tartrate

Country	Patent Number	Title	Estimated Expiration
China	105777707
Taiwan	I586663
Ecuador	SP12011926
Japan	2021506789
Japan	6452635
Canada	2453978	SYNTHESE D'INHIBITEURS DE L'UDP-GLUCOSE : N-ACYLSPHINGOSINE GLYCOSYLTRANSFERASE (SYNTHESIS OF UDP-GLUCOSE: N-ACYLSPHINGOSINE GLUCOSYLTRANSFERASE INHIBITORS)
Argentina	121611

Supplementary Protection Certificates for eliglustat tartrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	244 4-2015	Slovakia		PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
1409467	92717	Luxembourg		PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
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	15C0036	France		PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119

Eliglustat Tartrate (Cerdelga): Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is eliglustat tartrate and how is it positioned commercially?

Eliglustat tartrate (Cerdelga) is an oral, substrate reduction therapy for adults with Gaucher disease type 1 (GD1) who have a specific cytochrome P450 metabolizer status (CYP2D6), aligning treatment with genotype/phenotype-guided dosing.

Core market positioning

• Mechanism: substrate reduction therapy (reduces glucosylceramide).
• Administration: oral drug, intended to replace or reduce reliance on intravenous enzyme replacement therapy (ERT).
• Prescribing constraint: label-driven restriction by CYP2D6 metabolizer status, which limits treatable segments and shifts commercial demand toward compliant patient identification pathways. (U.S. Prescribing Information, Cerdelga) [1]

Manufacturer and commercialization history

• Originator: Genzyme (Sanofi), with global stewardship through Sanofi entities. (FDA label history and approvals) [1]

How large is the addressable population and what shapes demand?

Demand for Cerdelga tracks the treated GD1 population that meets both clinical criteria and dosing eligibility. The market dynamics are dominated by four forces: patient identification, payer acceptance, competitive substitution vs ERT, and ongoing adoption in treatment pathways.

1) Patient identification and access

• GD1 patient diagnosis rates and the speed of genotyping/phenotyping (for CYP2D6 status) directly affect initiation volume.
• Because eliglustat dosing depends on metabolizer status, uptake depends on prescriber workflow and lab access. (Cerdelga U.S. Prescribing Information, CYP2D6 dosing and contraindications) [1]

2) Payer and health technology assessment (HTA) posture

• In chronic rare disease, payers often negotiate to manage lifelong therapy costs.
• Formularies and prior authorization tend to require:
  • confirmation of GD1 diagnosis
  • metabolizer status confirmation
  • treatment history (naive vs switched from ERT)

3) Treatment pathway substitution vs ERT

• ERT remains a structural comparator. Eliglustat competes on:
  • oral convenience
  • home administration feasibility
  • long-term adherence dynamics
• Substitution is usually strongest after stable response on ERT or when patients prefer oral therapy, subject to payer rules and clinician confidence in monitoring.

4) Safety, drug-drug interaction burden, and adherence

• Eliglustat is sensitive to drug-drug interactions driven by CYP pathways.
• The label includes restrictions around contraindicated or cautionary co-medications, which affects real-world utilization. (Cerdelga U.S. Prescribing Information, drug interactions and CYP2D6) [1]

What market trends influenced growth or erosion over time?

Eliglustat’s trajectory reflects the rare disease commercial cycle: initial adoption after launch, consolidation with ERT in stable patients, and later shifts with the entry of other GD1 oral or emerging modalities.

Adoption phase dynamics

• Early growth typically follows:
  • increased clinician familiarity
  • improved access to CYP2D6 testing workflows
  • payer acceptance for eligible subpopulations

Consolidation and churn dynamics

• Over time, demand stabilizes as:
  • high-eligibility patients are treated
  • remaining patients cycle more slowly due to testing barriers and strict contraindication screens
• Churn risk exists when:
  • metabolizer status changes is not expected, but practical barriers (drug interaction screens) block continuation
  • payer policy tightens on prior authorization

Competition and treatment alternatives

• The GD1 market remains crowded with ERTs and other pipeline options, but eliglustat’s differentiator stays centered on oral delivery and genotype-based dosing.

How has the drug performed financially for the business?

Cerdelga’s financial trajectory is best assessed through Sanofi’s segment reporting and rare disease portfolio reporting. However, without verified, line-item sales data in the provided sources, a complete and accurate multi-year revenue table cannot be produced under strict evidentiary constraints.

What can be stated with source-backed precision

• Cerdelga is an FDA-approved therapy with label indications and dosing rules tied to CYP2D6 metabolizer status. This regulatory framework directly influences commercial coverage and patient access. (Cerdelga U.S. Prescribing Information) [1]

What cannot be stated accurately here

• Multi-year net sales, segment contribution, or year-over-year growth rates cannot be provided without audited financial disclosures or a cited sales dataset in the materials referenced.

What are the regulatory milestones that affect commercial momentum?

Key regulatory items that shape demand include the approved indication boundaries and dosing constraints.

FDA approval and label structure

• Indication: treatment of adults with Gaucher disease type 1 who have metabolizer status that allows safe dosing per label criteria. (U.S. Prescribing Information) [1]
• Dosing governance: CYP2D6 phenotype/genotype drives dosing and contraindicated states. (U.S. Prescribing Information) [1]

Regulatory structure matters commercially because it determines how quickly physicians can convert diagnosis into first prescription.

How do payer and reimbursement dynamics typically manifest in rare disease oral GD1?

In practice, payer dynamics for Cerdelga tend to cluster into these recurring patterns:

• Coverage gatekeeping:
  • metabolizer status confirmation
  • documentation of GD1 diagnosis
  • step edits after ERT failures or prior treatment history requirements
• Cost containment:
  • restricted formularies
  • negotiated rebates and patient assistance
• Outcome-linked negotiations:
  • response monitoring (biomarkers and clinical endpoints) used to justify continuation

These mechanisms affect realized net price and the volume of new starts each period.

Competitive and substitution dynamics: where does Cerdelga win?

Eliglustat typically wins when:

• patients want oral administration (preference and logistic advantage)
• patients face barriers to infusion schedules or infusion center availability
• clinicians can manage interaction risk and follow label dosing rules

Eliglustat faces headwinds when:

• patients are blocked by contraindicated co-medications
• access to CYP2D6 testing is delayed or inconsistent
• payers require documentation that slows initiation

Commercial KPIs that best track the financial trajectory

Even without revenue line items, the market trajectory for an oral rare disease asset can be tracked using operational KPIs that map closely to sales outcomes:

• New patient starts
  • number of eligible GD1 patients converted into prescriptions each quarter
• Persistence and adherence
  • ongoing therapy continuity after interaction screening and tolerability checks
• Prescriber conversion efficiency
  • time from diagnosis and genotype availability to first prescription
• Payer authorization throughput
  • approval cycle time and denial rates

These indicators predict revenue movement more directly than broad market narratives.

Key Takeaways

• Eliglustat tartrate (Cerdelga) is commercially constrained and directed by label-governed CYP2D6 metabolizer status dosing, which shapes patient eligibility, prescriber workflow, and payer authorization outcomes. [1]
• Market dynamics in GD1 are driven by diagnosis-to-testing conversion, payer acceptance of lifelong oral therapy, and substitution against ERT based on patient suitability and drug interaction burden. [1]
• A fully sourced multi-year financial revenue trajectory (net sales, growth rates, or segment contribution) cannot be produced from the provided material set; however, the regulatory framework that governs eligibility is the primary factor that determines volume conversion into prescriptions and thus financial direction. [1]

FAQs

1) What limits eliglustat use in the GD1 market?
CYP2D6 metabolizer status rules and contraindicated or cautionary drug-drug interactions can restrict eligibility and initiation. [1]

2) Is eliglustat a substitute or add-on versus enzyme replacement therapy?
It is used as an oral alternative within treatment pathways for eligible adult GD1 patients, often competing for substitution rather than being uniformly used as an add-on. (Label positioning within adult GD1 treatment) [1]

3) What drives prescription volume for Cerdelga?
The speed and completeness of GD1 diagnosis-to-CYP2D6 testing conversion, plus payer authorization and safe co-medication screening. [1]

4) How does oral administration affect adoption dynamics?
Oral delivery can improve convenience and reduce infusion dependency, but safe dosing constraints and interaction screens determine who can start and persist. [1]

5) Where does commercial risk typically concentrate?
In access friction (testing and authorization), metabolizer-status eligibility constraints, and interruption risk due to co-medication restrictions that affect continuation. [1]

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References

[1] U.S. Food and Drug Administration. Cerdelga (eliglustat tartrate) prescribing information. FDA Label.