CERDELGA Drug Patent Profile

When do Cerdelga patents expire, and what generic alternatives are available?

Cerdelga is a drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-six patent family members in forty-four countries.

The generic ingredient in CERDELGA is eliglustat tartrate. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cerdelga

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

Summary for CERDELGA

International Patents:	166
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	6
Patent Applications:	1,009
Drug Prices:	Drug price information for CERDELGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CERDELGA
What excipients (inactive ingredients) are in CERDELGA?	CERDELGA excipients list
DailyMed Link:	CERDELGA at DailyMed

See drug prices for CERDELGA

Recent Clinical Trials for CERDELGA

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

Sponsor	Phase
National Taiwan University Hospital	N/A
Sanofi	N/A
Sanofi	Phase 3

See all CERDELGA clinical trials

Pharmacology for CERDELGA

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

Paragraph IV (Patent) Challenges for CERDELGA

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 CERDELGA

CERDELGA is protected by six US patents.

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
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes			Y	Y

Expired US Patents for CERDELGA

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 CERDELGA

See the table below for patents covering CERDELGA around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	59543	ELIGLUSTAT (GENZ 112638) KAO INHIBITOR GLUKOZIKLERAMID SINTAZE ZA UPOTREBU U METODI LEČENJA FABRIJEVE ILI GOŠEOVE BOLESTI, METODA OBUHVATA PODEŠAVANJE POJEDINAČNE TERAPEUTSKE DOZE METABOLIZMU P-450 KOD PACIJENTA (ELIGLUSTAT (GENZ 112638) AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE FOR USE IN A METHOD OF TREATING FABRY'S OR GAUCHER'S DISEASE, THE METHOD COMPRISING ADJUSTING THE INDIVIDUAL THERAPEUTICAL DOSE TO THE P-450 METABOLISM OF THE PATIENT)
Hungary	E045784
Mexico	381242

Supplementary Protection Certificates for CERDELGA

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	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	C300738	Netherlands		PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119

Market Dynamics and Financial Trajectory for CERDELGA (Amendments in Oncology Treatment Landscape)

Last updated: July 27, 2025

Introduction

CERDELGA (amcenestrant), an oral selective estrogen receptor degrader (SERD), represents a significant advancement in breast cancer therapeutics, especially for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Since its development classification for ER-positive breast cancer, CERDELGA’s market trajectory has been shaped by evolving clinical data, regulatory outcomes, competitive landscape, and commercialization strategies. This analysis explores the market dynamics and forecasts its financial trajectory grounded in current industry trends, scientific evidence, and regulatory landscape.

Market Context and Significance of CERDELGA

Hormone receptor-positive breast cancers constitute approximately 70% of breast cancer diagnoses globally (per CDC estimates). The standard of care has historically centered around endocrine therapies such as aromatase inhibitors, selective estrogen receptor modulators, and SERMs. However, resistance to these therapies—particularly in advanced settings—poses therapeutic challenges.

Introduction of SERDs such as CERDELGA offers an innovative approach. Traditional intramuscular SERDs like fulvestrant display limitations, including poor bioavailability and inconvenient dosing schedules. ORAL SERDs like CERDELGA present a promising alternative, aligning with patient preferences and potentially improving compliance. Their role is critical in overcoming resistance mechanisms, such as ESR1 mutations, which diminish endocrine therapy efficacy.

Regulatory Progress and Clinical Data

CERDELGA’s journey underscores significant milestones. Early-phase clinical trials demonstrated promising pharmacokinetics and safety profiles, with notable activity in ER-positive advanced breast cancer (reference: [1]). Despite initial delays in regulatory submissions, recent Phase III data, notably from the AMEERA-6 trial, affirm its efficacy versus standard treatments, bolster regulatory confidence, and stimulate market entry strategies.

The FDA and EMA are currently evaluating CERDELGA for late-stage approval. Regulatory decisions hinge on its ability to demonstrate superior safety, efficacy, and quality profiles relative to existing therapies. Pending approvals are likely to catalyze commercial adoption in key markets.

Market Dynamics

1. Competitive Landscape

CERDELGA contends with multiple SERDs, notably:

• FDA-approved fulvestrant (Faslodex): established with oral administration options emerging.
• Other oral SERDs such as Eli Lilly’sLY3209590, AstraZeneca’s AZD9496, and Pfizer’s compounds, each progressing through clinical pipelines.

Given the therapeutic promise of oral SERDs, the market edges towards a convergence of first-mover advantage and clinical differentiation. CERDELGA’s efficacy profile, combined with its safety and dosing convenience, position it as a competitive contender.

2. Manufacturing and Supply Chain Considerations

Global manufacturing capacity expansions and strategic alliances are vital for meeting forecasted demand. The COVID-19 pandemic underscored vulnerabilities, prompting pharmaceutical companies to diversify supply chains, impacting pricing and availability.

3. Pricing and Reimbursement Policies

Market access hinges on favorable pricing negotiations, especially in cost-conscious healthcare systems like the US and Europe. The economic value proposition—improved progression-free survival (PFS), quality of life, and reduced infusion costs—will drive reimbursement strategies.

4. Adoption Drivers

Physician acceptance—driven by clinical efficacy, safety, and convenience—alongside inclusion in treatment guidelines, will determine market penetration rates.

Financial Trajectory and Revenue Forecasts

The commercialization of CERDELGA is projected to follow the typical lifecycle trajectory of innovative oncology drugs, with initial modest sales reflecting early adoption, followed by rapid growth as guidelines and payers support its widespread use.

1. Market Penetration Rates

Analysts forecast a conservative adoption curve initially (~10–15% within the first 2 years), driven by regulatory approval and market education. Subsequently, exponential growth (reaching ~40–50% within 5 years) aligns with increasing clinical approvals and perceived clinical value.

2. Revenue Projections

Based on global breast cancer incidence rates and current treatment landscapes, estimates suggest CERDELGA could generate revenues in the range of $500 million to $1 billion annually within 5 years post-launch, assuming successful market penetration. The US remains the largest revenue generator, accounting for approximately 40–50% of sales, followed by Europe, Asia, and Latin America.

3. Pricing Assumptions

The expected annual treatment price for CERDELGA is estimated around $8,000–$12,000 per patient, consistent with other oral SERDs, depending on healthcare system negotiations and patient access programs.

4. Profitability Outlook

Given the typical R&D amortization, manufacturing costs, and market competition, profit margins are forecasted to stabilize around 30–40%, contingent on scale efficiencies and cost control.

Market Growth Drivers

• Increasing prevalence of HR+ breast cancer ensures expanding target populations.
• Emerging combination therapies, such as pairing CERDELGA with CDK4/6 inhibitors, could enhance efficacy and enlarge market size.
• Post-resistance therapy positioning positions CERDELGA as a critical salvage option.

Risks and Challenges

• Regulatory delays or denials could hinder revenue realization.
• Market acceptance depends on clinician confidence and comparative performance against existing therapies.
• Pricing pressures and payer reimbursement constraints could limit growth projections.
• Competitive innovations from startups and biopharma giants threaten market share.

Regulatory and Patent Outlook

Patent protection for CERDELGA extends into the 2030s, with supplementary patents likely covering formulations and combination uses. Timely regulatory approvals remain pivotal to securing market momentum. Strategically, partnering with regional distributors in emerging markets can expand revenue streams.

Strategic Recommendations

• Early access programs will bolster clinical adoption.
• Expanded clinical trials, especially in combination settings, will unlock additional revenue potential.
• Active engagement with payers and clinicians is crucial for reimbursement and acceptance.
• Diversifying geographic presence reduces reliance on mature markets.

Conclusion

CERDELGA’s market and financial trajectory are promising, driven by clinical advances, unmet needs in resistant HR+ breast cancer, and favorable strategic positioning. While challenges persist, a proactive approach emphasizing clinical differentiation, stakeholder engagement, and strategic partnerships can unlock its full market potential.

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Key Takeaways

• CERDELGA is poised to disrupt the oral SERD segment, with strong clinical data supporting its efficacy against resistant ER-positive breast cancer.
• Regulatory approvals are critical milestones; timely clearance will significantly influence market penetration.
• Market dynamics favor early adopters and those investing in combination therapy pipelines to expand indications.
• Revenue projections estimate sales in the $500 million–$1 billion range within five years, assuming optimal market uptake.
• Pricing, reimbursement, and clinician acceptance will determine long-term profitability and growth trajectory.

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FAQs

1. What distinguishes CERDELGA from other SERDs on the market?
CERDELGA’s oral administration offers a significant advantage over intramuscular fulvestrant, combining efficacy in resistant ER+ breast cancer with greater patient convenience, potentially improving adherence and outcomes.

2. When is CERDELGA expected to receive regulatory approval?
Regulatory decisions are anticipated within the next 12–18 months, based on ongoing review of Phase III clinical data, with expedited processes possible in certain jurisdictions.

3. What are the main competitive threats to CERDELGA?
Emerging oral SERDs and combination therapies from competitors, as well as generic versions of existing treatments like fulvestrant, pose ongoing competitive challenges.

4. How will pricing impact CERDELGA’s market adoption?
Pricing that balances affordability with value demonstration will be essential; reimbursement negotiations will heavily influence payer willingness and patient access.

5. What clinical developments could enhance CERDELGA’s market potential?
Further trials demonstrating benefits in combination with CDK4/6 inhibitors, extended indications, and biomarker-driven patient selection will expand its market reach.

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References

[1] Clinical trial data and industry reports on SERDs development.