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FILSPARI Drug Patent Profile

When do Filspari patents expire, and when can generic versions of Filspari launch?

Filspari is a drug marketed by Travere and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in fourteen countries.

The generic ingredient in FILSPARI is sparsentan. One supplier is listed for this compound. Additional details are available on the sparsentan profile page.

DrugPatentWatch^® Generic Entry Outlook for Filspari

Filspari will be eligible for patent challenges on February 17, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FILSPARI

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	1
Patent Applications:	61
Drug Prices:	Drug price information for FILSPARI
What excipients (inactive ingredients) are in FILSPARI?	FILSPARI excipients list
DailyMed Link:	FILSPARI at DailyMed

See drug prices for FILSPARI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FILSPARI

Constraining patent/regulatory exclusivity:

TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON FEBRUARY 17, 2023

NDA:

216403

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FILSPARI

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

Sponsor	Phase
Travere Therapeutics, Inc.	Phase 2

See all FILSPARI clinical trials

Pharmacology for FILSPARI

Drug Class	Angiotensin 2 Receptor Blocker Endothelin Receptor Antagonist
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Endothelin Receptor Antagonists P-Glycoprotein Inhibitors

US Patents and Regulatory Information for FILSPARI

FILSPARI is protected by two US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON FEBRUARY 17, 2023.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No

International Patents for FILSPARI

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1244687	治療腎小球硬化症的二苯基磺酰胺內皮素和血管緊張素II受體拮抗劑 (A DIPHENYLSULFONAMIDE ENDOTHELIN AND ANGIOTENSIN II RECEPTOR ANTAGONISTS TO TREATGLOMERULOSCLEROSIS)
Hungary	E033494
Croatia	P20171197
Japan	2017008081	血圧上昇および糖尿病性腎症を処置するための、ビフェニルスルホンアミドエンドセリンおよびアンジオテンシンＩＩ受容体アンタゴニストの経口製剤 (ORAL FORMULATIONS OF BIPHENYLSULFONAMIDE ENDOTHELIN AND ANGIOTENSIN II RECEPTOR AGONISTS TO TREAT ELEVATED BLOOD PRESSURE AND DIABETIC NEPHROPATHY)
Spain	2811342
European Patent Office	3222277	ANTAGONISTE DES RÉCEPTEURS DE L'ENDOTHÉLINE ET DE L'ANGIOTENSINE II À BASE DE BIPHÉNYLSULFONAMIDE POUR TRAITER LA GLOMÉRULOSCLÉROSE ET LA NEPHROPATHIE INDUITE PAR L'IGA (A BIPHENYLSULFONAMIDE ENDOTHELIN AND ANGIOTENSIN II RECEPTOR ANTAGONIST TO TREAT GLOMERULOSCLEROSIS AND IGA-INDUCED NEPHROPATHY)

Market Dynamics and Financial Trajectory for FILSPARI (Sparsentan)

Introduction to FILSPARI

FILSPARI (sparsentan) is a groundbreaking drug developed by Travere Therapeutics, specifically designed to treat IgA Nephropathy (IgAN), a rare kidney disease. Here, we delve into the market dynamics and financial trajectory of FILSPARI, highlighting its recent milestones, commercial performance, and future prospects.

FDA Approval and Regulatory Milestones

On September 5, 2024, the U.S. Food and Drug Administration (FDA) granted full approval to FILSPARI for slowing kidney function decline in adults with primary IgAN who are at risk of disease progression. This approval marked a significant milestone, making FILSPARI the only non-immunosuppressive treatment for this condition[1][2][4].

Commercial Performance

The commercial launch of FILSPARI has been robust. In the third quarter of 2024, Travere Therapeutics reported net product sales of $35.6 million for FILSPARI, representing a 30% growth from the previous quarter. Since its launch in February 2023, the company has received a total of 2,989 patient start forms (PSFs), with 505 new PSFs in the third quarter alone[1][2][4].

Revenue and Financial Highlights

For the third quarter of 2024, Travere Therapeutics reported total revenue of $62.9 million, a 69% increase from the same period in 2023. This growth is primarily driven by the sales of FILSPARI, which contributed $35.6 million to the total net product sales of $61.0 million[1][2][4].

Year-to-Date Performance

Year-to-date, FILSPARI's net product sales have totaled $82.6 million, indicating strong demand and market acceptance. The overall financial performance is bolstered by the company's other products, including tiopronin, which contributed $25.4 million in net product sales for the third quarter[1][2].

Operating Expenses and Net Loss

Despite the strong revenue growth, Travere Therapeutics reported a net loss of $54.8 million for the third quarter of 2024. This loss is attributed to various factors, including a one-time gain from a product sale recognized in the previous year and ongoing research and development expenses. R&D expenses for the third quarter were $51.7 million, down from $60.6 million in the same period of 2023 due to restructuring initiatives and the advancement of clinical programs[2][4].

Cash Position and Financial Stability

As of September 30, 2024, Travere Therapeutics had a strong cash position with $277.4 million in cash, cash equivalents, and marketable securities. This financial stability is crucial as the company continues to invest in its growth initiatives and navigates the path to profitability[2][4].

Market Dynamics and Growth Drivers

Several factors are driving the growth of FILSPARI in the market:

Updated KDIGO Guidelines

The Kidney Disease Improving Global Outcomes (KDIGO) published draft guidelines in August 2024, recommending FILSPARI as a foundational kidney-targeted therapy for IgAN. These guidelines lower the targeted proteinuria level for all IgAN patients, which is expected to drive more ambitious treatment strategies and increase the adoption of FILSPARI[2].

Clinical Data and Presentations

Travere Therapeutics presented several abstracts on FILSPARI at the ASN Kidney Week, highlighting its superior long-term durable benefits on proteinuria and kidney function preservation. This growing body of data supports earlier and combination treatments, further solidifying FILSPARI's position in the market[2].

Regulatory Discussions and Future Indications

The company is preparing for FDA discussions to establish a path for sparsentan's supplemental New Drug Application (sNDA) submission in Focal Segmental Glomerulosclerosis (FSGS). Additionally, an sNDA requesting a modification to the frequency of liver monitoring for FILSPARI has been submitted to the FDA[1][2][4].

Future Prospects and Outlook

Travere Therapeutics is optimistic about the growth potential of FILSPARI. The company expects continued strong demand driven by the full approval label, updated KDIGO guidelines, and the growing body of clinical data. With anticipated milestone payments from CSL Vifor for FILSPARI's full approval in Europe, the company is confident in its ability to reach more patients with IgAN and expand its market presence[2][4].

Challenges and Considerations

While the financial trajectory of FILSPARI is promising, there are challenges to consider. The net loss in the third quarter, although attributed to specific factors, highlights the ongoing investment in R&D and commercial activities. Additionally, the company operates with a moderate level of debt, though its liquid assets exceed short-term obligations, providing some financial stability[4].

Key Takeaways

• Full FDA Approval: FILSPARI received full FDA approval for treating IgAN, marking a significant milestone.
• Strong Commercial Performance: Net product sales of $35.6 million in Q3 2024, with a 30% quarter-over-quarter growth.
• Updated KDIGO Guidelines: Recommendations supporting FILSPARI as a foundational therapy for IgAN.
• Future Indications: Ongoing discussions for sNDA submission in FSGS and modifications to liver monitoring.
• Financial Stability: Strong cash position of $277.4 million as of September 30, 2024.

FAQs

What is FILSPARI, and what is it used for?

FILSPARI (sparsentan) is a drug approved by the FDA for treating IgA Nephropathy (IgAN), a rare kidney disease. It is the only non-immunosuppressive treatment that significantly slows kidney function decline in adults with primary IgAN.

What were the key financial highlights for FILSPARI in Q3 2024?

In Q3 2024, FILSPARI generated $35.6 million in net product sales, contributing to a total revenue of $62.9 million for Travere Therapeutics. This represents a 30% growth in net sales from the previous quarter.

What are the updated KDIGO guidelines, and how do they impact FILSPARI?

The updated KDIGO guidelines recommend FILSPARI as a foundational kidney-targeted therapy for IgAN, lowering the targeted proteinuria level for all IgAN patients. This is expected to drive more ambitious treatment strategies and increase the adoption of FILSPARI.

Is FILSPARI being considered for other indications?

Yes, Travere Therapeutics is preparing for FDA discussions to establish a path for sparsentan's sNDA submission in Focal Segmental Glomerulosclerosis (FSGS).

What is the current cash position of Travere Therapeutics?

As of September 30, 2024, Travere Therapeutics had $277.4 million in cash, cash equivalents, and marketable securities.

Cited Sources:

1. Travere Therapeutics Reports Third Quarter 2024 Financial Results - [GlobeNewswire][2]
2. Travere Therapeutics Reports Third Quarter 2024 Financial Results - [Travere Therapeutics IR][1]
3. Travere Therapeutics Reports First Quarter 2024 Financial Results - [GlobeNewswire][3]
4. Earnings call: Travere reports robust Q3 growth, eyes FILSPARI expansion - [Investing.com][4]
5. Travere Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results - [GlobeNewswire][5]