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-four 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:	164
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	6
Patent Applications:	56
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	10,888,547
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
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	7,196,205			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	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 CERDELGA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2015212291	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 FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE)
Canada	3083663	METHODES DE TRAITEMENT DE LA MALADIE DE GAUCHER (METHODS FOR TREATING GAUCHER DISEASE)
Hong Kong	1153733
Israel	283935	צורה גבישית ואמורפית של genz 112638 המיטארטראט כמעכב של גלוקוזילסראמיד סינטאז (An amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase)
Spain	2875382
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	C20150027 00161	Estonia		PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
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
1409467	244 4-2015	Slovakia		PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
1409467	CR 2015 00035	Denmark		PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
1409467	92717	Luxembourg		PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121

Market Dynamics and Financial Trajectory for Cerdelga

Introduction to Cerdelga

Cerdelga, developed by Sanofi, is a significant drug in the treatment of Gaucher disease type 1 (GD1), a rare genetic disorder. It is an inhibitor of glucosylceramide synthase, approved for the long-term treatment of adult patients with GD1 who are CYP2D6 poor metabolizers, intermediate metabolizers, or extensive metabolizers[4].

Market Position of Cerdelga

Within the Gaucher Disease Market

The global Gaucher disease drugs market, valued at USD 1.65 billion in 2022, is expected to expand at a CAGR of 2.6% from 2023 to 2030. Cerdelga, as a substrate reduction therapy (SRT), is part of this growing market. SRT is anticipated to grow at the fastest CAGR of 9.3% due to its ease of treatment and cost savings compared to other therapies[1].

Competitive Landscape

Cerdelga competes in a market dominated by enzyme replacement therapy (ERT), with drugs like Cerezyme, Vpriv, and Elelyso leading the segment. However, SRT, including Cerdelga and Zavesca, is gaining traction due to its oral administration and cost-effectiveness[1].

Financial Performance of Cerdelga

Recent Sales Figures

In Q2 2024, Cerdelga sales reached €82 million, marking a 7.8% increase compared to the same period in 2023. This growth is underpinned by continued expansion in all regions[5].

Historical Sales Growth

Cerdelga has shown consistent growth over the years. In Q4 2021, its sales increased by 11.9% to €67 million, and for the full year 2021, sales rose by 11.1% to €254 million[3].

Contribution to Sanofi's Revenue

Cerdelga is a significant contributor to Sanofi's revenue, particularly within the rare diseases segment. Sanofi's overall net sales in Q2 2024 were €10,745 million, with the biopharma segment, which includes Cerdelga, growing by 10.3% at constant exchange rates (CER)[5].

Market Drivers

Increasing Incidence and Diagnosis

The rising incidence of Gaucher disease and increasing efforts to identify more patients are key drivers for the market. As more patients are diagnosed, the demand for effective treatments like Cerdelga is expected to increase[1].

Ease of Treatment and Cost Savings

Cerdelga's oral administration and cost savings compared to ERT make it an attractive option for patients. This ease of treatment is a significant factor in its growing adoption[1].

Regulatory and Clinical Aspects

Approval and Clinical Trials

Cerdelga was authorized based on two pivotal trials, Engage and Encore, which confirmed its safety and efficacy in patients with GD1. The drug was approved by the U.S. FDA for the long-term treatment of adult patients with GD1[4].

Patient Metabolizer Status

Cerdelga's efficacy has been demonstrated across different CYP2D6 metabolizer statuses, making it a versatile treatment option for a broader patient population[4].

Competitive Advantage

Unique Mechanism of Action

Cerdelga's mechanism as a glucosylceramide synthase inhibitor sets it apart from ERTs. This unique action helps in reducing the accumulation of glucosylceramide in cells, providing an alternative treatment pathway for patients[4].

Patient Compliance

The oral administration of Cerdelga enhances patient compliance compared to the intravenous administration required for ERTs. This convenience is a significant advantage in the long-term management of GD1[1].

Challenges and Opportunities

Market Competition

Despite its growth, Cerdelga faces competition from established ERTs and other SRTs. Maintaining market share and expanding its user base will be crucial for its continued success[1].

Expanding Patient Base

As diagnostic efforts improve, there is an opportunity to expand the patient base for Cerdelga. Increasing awareness and early diagnosis of Gaucher disease can drive further growth[1].

Financial Outlook

Sales Projections

Given the current growth trends, Cerdelga is expected to continue its upward sales trajectory. The overall Gaucher disease market's modest growth and the specific growth rate of SRTs suggest a positive financial outlook for Cerdelga[1].

Impact on Sanofi's Financials

Cerdelga's performance is integral to Sanofi's financial health, particularly within the biopharma segment. Strong sales growth from Cerdelga contributes to Sanofi's overall revenue and profitability[5].

Key Takeaways

• Market Growth: Cerdelga is part of the growing Gaucher disease drugs market, expected to expand at a CAGR of 2.6% from 2023 to 2030.
• Sales Performance: Cerdelga has shown consistent sales growth, with a 7.8% increase in Q2 2024.
• Competitive Advantage: Its unique mechanism of action and oral administration enhance patient compliance and cost savings.
• Regulatory Approval: Authorized based on pivotal trials, Cerdelga is effective across different CYP2D6 metabolizer statuses.
• Financial Outlook: Positive sales projections and contributions to Sanofi's revenue highlight a strong financial trajectory.

FAQs

What is Cerdelga used for?

Cerdelga is used for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).

How does Cerdelga work?

Cerdelga works by inhibiting glucosylceramide synthase, reducing the accumulation of glucosylceramide in cells.

What are the key benefits of Cerdelga?

Cerdelga offers ease of treatment through oral administration and cost savings compared to enzyme replacement therapy (ERT).

Who are the main competitors of Cerdelga?

Cerdelga competes with ERTs like Cerezyme, Vpriv, and Elelyso, as well as other SRTs such as Zavesca.

What is the current market size and growth rate of the Gaucher disease drugs market?

The global Gaucher disease drugs market was valued at USD 1.65 billion in 2022 and is expected to grow at a CAGR of 2.6% from 2023 to 2030[1].

Sources

1. Grand View Research: Gaucher Disease Drugs Market Size & Share Report, 2030.
2. GlobeNewswire: Press Release - Sanofi continues to deliver strong business EPS growth driven by higher sales and improved margins in Q1.
3. Sanofi: Press Release - Strong 2021 sales and business EPS growth.
4. Health Canada: Summary Basis of Decision for Cerdelga.
5. Sanofi: Q2: strong performance with 10% sales growth; 2024.