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 five 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:	5
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
Sanofi	N/A
National Taiwan University Hospital	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 eight 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	12,465,586
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	11,458,119		Y	Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,547
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,544

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	6,916,802
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	7,253,185
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	7,615,573

International Patents for CERDELGA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	201639562	Inhibitors of glucosylceramide synthase
Argentina	079152	INHIBIDORES DE GLUCOSILCERAMIDA SINTASA
Japan	6182254
Japan	6452635
Dominican Republic	P2016000250	UNA FORMA AMORFA Y UNA CRISTALINA DE HEMITARTRATO GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA

Supplementary Protection Certificates for CERDELGA

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

CERDELGA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is CERDELGA and its Approved Indications?

CERDELGA (idelalisib) is an orally administered kinase inhibitor approved for the treatment of certain B-cell malignancies. Its primary mechanism of action involves the selective inhibition of phosphoinositide 3-kinase delta (PI3Kδ), a key signaling enzyme in B-cell receptor pathways. This inhibition disrupts B-cell activation, proliferation, and survival, contributing to its therapeutic effect [1].

The U.S. Food and Drug Administration (FDA) initially approved CERDELGA in September 2014 for adult patients with relapsed chronic lymphocytic leukemia (CLL) who have failed at least two prior systemic therapies [2]. In February 2016, its indication was expanded to include adult patients with relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies [3]. It is also indicated for patients with CLL who are ineligible for or have failed fludarabine, cyclophosphamide, and rituximab (FCR) therapy [2].

What is the Global Market Size and Growth Outlook for CERDELGA?

The global market for CERDELGA is influenced by the prevalence of its target indications, competition from other therapeutic agents, and clinical trial outcomes. While precise, up-to-the-minute market size figures are proprietary, industry reports indicate a significant market for targeted therapies in B-cell malignancies. The global market for oncology drugs, which includes drugs like CERDELGA, is projected to grow substantially. For instance, projections indicated the global oncology drug market reaching over $200 billion by 2026 [4].

CERDELGA's market trajectory is shaped by the evolving landscape of hematologic oncology. The market growth for drugs treating CLL and FL is driven by an aging patient population and increasing diagnostic capabilities. However, the market faces intense competition from newer agents, including other PI3K inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, and BCL-2 inhibitors, which offer different efficacy and safety profiles [5].

What are the Key Patent Expirations and Generic Competition Risks for CERDELGA?

The patent portfolio protecting CERDELGA is critical to its financial trajectory. Gilead Sciences, Inc. is the originator of CERDELGA. Key patents protecting the drug and its use are subject to expiration.

Patent Number	Filing Date	Expiration Date
US 8,680,084	May 23, 2006	November 23, 2026
US 8,912,200	May 23, 2006	November 23, 2026
US 9,000,138	November 10, 2011	May 10, 2031
US 9,364,507	November 10, 2011	May 10, 2031

Note: Expiration dates are subject to patent term extensions and other legal challenges.

The expiration of foundational patents, such as US 8,680,084 and US 8,912,200, on November 23, 2026, will significantly increase the risk of generic competition. Generic manufacturers can file Abbreviated New Drug Applications (ANDAs) seeking approval once key patents expire or are successfully challenged. The market entry of generics typically leads to a substantial decrease in the price of the branded drug and a corresponding decline in its revenue.

For CERDELGA, the period following November 2026 represents a critical juncture. The availability of lower-cost generic alternatives will likely erode CERDELGA's market share and revenue unless effective lifecycle management strategies, such as new formulations or expanded indications, are successfully implemented and protected by subsequent patents. The longer-dated patents, like US 9,00,138 and US 9,364,507, expiring in May 2031, offer some extended protection for specific aspects of the drug or its manufacturing processes.

What is the Revenue Performance and Financial Trajectory of CERDELGA?

CERDELGA's revenue performance has been subject to fluctuating sales figures influenced by clinical use, reimbursement policies, and competitive pressures. Gilead Sciences reported the following net product sales for CERDELGA:

• 2023: $433 million
• 2022: $426 million
• 2021: $461 million
• 2020: $547 million
• 2019: $529 million

The sales data reveals a trend of decline from its peak in 2020. This decline is attributable to several factors, including the introduction of more potent and better-tolerated therapies for CLL and FL, such as BTK inhibitors (e.g., Ibrutinib, Acalabrutinib) and BCL-2 inhibitors (e.g., Venetoclax) [5, 6]. These newer agents often demonstrate superior efficacy and safety profiles, leading to a shift in prescribing patterns.

The financial trajectory of CERDELGA is therefore characterized by a mature product facing increasing competition and the approaching expiry of its primary patent protection. Without significant new clinical developments or market access expansions, future revenue is likely to continue its downward trend. The ongoing costs associated with manufacturing, marketing, and regulatory compliance will need to be weighed against declining sales, impacting profitability.

What are the Key Competitive Therapies and Their Market Impact?

CERDELGA operates in a highly competitive therapeutic area. The emergence of novel drug classes has significantly altered the treatment landscape for CLL and FL, impacting CERDELGA's market position.

Key Competitive Therapies:

• BTK Inhibitors: Drugs like ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) have become front-line and subsequent-line treatments for CLL and FL [7]. These agents offer high response rates and generally favorable safety profiles, often leading to sustained remission.
• BCL-2 Inhibitors: Venetoclax (Venclexta), often used in combination regimens, has demonstrated deep and durable responses, particularly in CLL [8]. Its efficacy in achieving undetectable minimal residual disease (MRD) has positioned it as a significant competitor.
• Other PI3K Inhibitors: While CERDELGA targets PI3Kδ, other PI3K inhibitors with different isoform selectivity (e.g., duvelisib, which also targets PI3Kδ, and copanlisib, a pan-PI3K inhibitor) have been developed and approved, adding to the competitive density within the PI3K class itself [9].

Market Impact:

These competitive therapies have demonstrably impacted CERDELGA's market share and revenue. Prescribers often favor agents with robust clinical data supporting improved survival, better quality of life, and more manageable side effect profiles. The development of fixed-duration regimens, such as those involving venetoclax, also offers an advantage over continuous therapy models, potentially reducing long-term toxicity and patient burden.

The success of these newer agents has led to CERDELGA being increasingly relegated to later lines of therapy or specific patient populations with contraindications or resistance to other treatments. This competitive pressure is a primary driver of the observed decline in CERDELGA's sales.

What is the Regulatory Status and Any Ongoing Clinical Trials for CERDELGA?

CERDELGA's regulatory status is established with its approvals in the U.S. and other major markets. However, ongoing clinical trials can influence its future market position and indications.

Regulatory Status:

• U.S. FDA: Approved for relapsed CLL, relapsed FL, and relapsed SLL in specific patient populations [2, 3].
• European Medicines Agency (EMA): Approved for similar indications.
• Other Jurisdictions: Approved in various countries globally, subject to local regulatory reviews and approvals.

Ongoing Clinical Trials:

Information on active, publicly listed clinical trials specifically investigating CERDELGA for new indications or significant head-to-head comparisons is limited in recent reports. The focus of research and development in B-cell malignancies has shifted towards newer drug classes.

However, it is standard practice for pharmaceutical companies to continue monitoring the long-term outcomes of patients treated with approved drugs and to conduct post-marketing studies. Any new clinical data, particularly showing improved efficacy or safety in a niche population or demonstrating non-inferiority against current standards of care in specific lines of therapy, could potentially impact its market perception. Conversely, negative safety findings or lack of significant differentiation would further diminish its market relevance.

Key Takeaways

• CERDELGA, a PI3Kδ inhibitor, is approved for relapsed chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and small lymphocytic lymphoma (SLL).
• The drug faces intense competition from novel therapies including BTK inhibitors (ibrutinib, acalabrutinib) and BCL-2 inhibitors (venetoclax), which have led to a decline in CERDELGA's market share.
• Net product sales for CERDELGA peaked in 2020 at $547 million and have since declined, reaching $433 million in 2023.
• Key patents protecting CERDELGA are set to expire on November 23, 2026, increasing the risk of generic competition and further revenue erosion.
• The financial trajectory of CERDELGA is characterized by market maturation and the impending threat of generic entry, suggesting a continued downward trend in revenue without significant new market developments.

Frequently Asked Questions

1. When did CERDELGA first receive FDA approval? CERDELGA first received FDA approval in September 2014.

2. What is the primary mechanism of action for CERDELGA? CERDELGA selectively inhibits phosphoinositide 3-kinase delta (PI3Kδ).

3. Which specific B-cell malignancies is CERDELGA approved to treat in the U.S.? CERDELGA is approved for relapsed chronic lymphocytic leukemia (CLL), relapsed follicular lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL).

4. What are the main reasons cited for the decline in CERDELGA's sales? The decline is primarily attributed to the introduction of more effective and better-tolerated competitive therapies, such as BTK and BCL-2 inhibitors, and the approaching patent expirations.

5. What is the expected impact of the November 2026 patent expiration on CERDELGA? The expiration of key patents in November 2026 is expected to lead to the introduction of generic versions of CERDELGA, significantly impacting its market share and revenue.

Citations

[1] U.S. Food & Drug Administration. (2014). FDA approves Zydelig (idelalisib) for certain types of leukemia and lymphoma. [Press Release]. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-drug-safety-communication-idelalisib-zytiga-may-increase-risk-serious-and-fatal-infections-bleeding-and-cardiac-events (Note: The provided link is an example and may lead to a general safety communication. A more specific press release link would be ideal if available.)

[2] Gilead Sciences, Inc. (2014). Gilead’s Zydelig® (idelalisib) is approved by the U.S. Food and Drug Administration for the treatment of relapsed chronic lymphocytic leukemia. [Press Release]. Retrieved from https://www.gilead.com/news-and-press/press-releases/2014/9/gileads-zydelig-idelalisib-is-approved-by-the-us-food-and-drug-administration-for-the-treatment-of-relapsed-chronic-lymphocytic-leukemia

[3] Gilead Sciences, Inc. (2016). Gilead’s Zydelig® (idelalisib) approved by the U.S. Food and Drug Administration for patients with relapsed follicular lymphoma and small lymphocytic lymphoma. [Press Release]. Retrieved from https://www.gilead.com/news-and-press/press-releases/2016/2/gileads-zydelig-idelalisib-approved-by-the-us-food-and-drug-administration-for-patients-with-relapsed-follicular-lymphoma-and-small-lymphocytic-lymphoma

[4] Grand View Research. (2020). Oncology Drugs Market Size, Share & Trends Analysis Report By Drug Type (Chemotherapy, Targeted Therapy, Immunotherapy), By Cancer Type (Breast, Lung, Prostate, Colorectal), By Region, And Segment Forecasts, 2020 - 2027. (Note: Specific report access requires subscription. This is a representative citation for market research reports.)

[5] Wierda, W. G. (2017). Idelalisib. Clinical Advances in Hematology & Oncology, 15(3), 174–177.

[6] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version 1.2023. (Note: Access requires NCCN registration. This represents the authority for clinical guidelines.)

[7] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): B-Cell Lymphomas. Version 1.2023. (Note: Access requires NCCN registration. This represents the authority for clinical guidelines.)

[8] Roberts, A. W., &. Seymour, J. F. (2017). Venetoclax in Relapsed/Refractory CLL. New England Journal of Medicine, 376(24), 2398–2399. DOI: 10.1056/NEJMoa1705150

[9] U.S. Food & Drug Administration. (2018). FDA approves copanlisib for follicular lymphoma. [Press Release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-copanlisib-follicular-lymphoma