Seladelpar lysine - Generic Drug Details

What are the generic drug sources for seladelpar lysine and what is the scope of freedom to operate?

Seladelpar lysine is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Seladelpar lysine has one hundred and thirty-eight patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for seladelpar lysine

International Patents:	138
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	89
What excipients (inactive ingredients) are in seladelpar lysine?	seladelpar lysine excipients list
DailyMed Link:	seladelpar lysine at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA

Dosage:

CAPSULE;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.

Anatomical Therapeutic Chemical (ATC) Classes for seladelpar lysine

A05AX	Other drugs for bile therapy
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

B05XB	Amino acids
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for seladelpar lysine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes			Y	Y

International Patents for seladelpar lysine

Country	Patent Number	Title	Estimated Expiration
Hungary	E025185
South Korea	20190015363	간내 담즙 정체성 질환의 치료
Spain	2378435
Eurasian Patent Organization	201691887

Supplementary Protection Certificates for seladelpar lysine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3119384	LUC50017	Luxembourg		PRODUCT NAME: SELADELPAR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR SELADELPAR L-LYSINE DIHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/24/1898 20250221
3119384	C20253004	Finland
3119384	122025000034	Germany		PRODUCT NAME: SELADELPAR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE SELADELPAR-L-LYSIN-DIHYDRAT; REGISTRATION NO/DATE: EU/1/24/1898 20250220
3119384	2025C/532	Belgium		PRODUCT NAME: SELADELPAR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER SELADELPAR L-LYSINEDIHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/24/1898 20250221

What Are the Market Dynamics for Seladelpar Lysine?

Last updated: February 15, 2026

Seladelpar lysine, a highly selective PPARδ agonist, is under investigation for conditions such as primary biliary cholangitis (PBC) and other liver disorders. Its market potential depends on regulatory approvals, clinical trial outcomes, patent protection, and competitive landscape.

Regulatory Status and Development Pipeline

Seladelpar lysine is advancing through clinical development phases. As of Q4 2023, it remains an investigational drug with no FDA approval. Its developer, Casdin Capital, is conducting Phase 3 trials, targeting PBC, with results anticipated in 2024. Regulatory agencies' decisions will impact market entry and subsequent revenue generation.

Clinical Trial Outcomes and Efficacy

Positive Phase 2 data demonstrated reductions in alkaline phosphatase and improvement in liver function tests. Phase 3 trial results are critical; they must show significant clinical benefit over existing therapies, such as ursodeoxycholic acid (UDCA) and obeticholic acid (OCA). A failure to meet endpoints would limit commercial prospects.

Competitive Landscape

Seladelpar lysine competes with established treatments like UDCA, OCA (Ocaliva), and emerging therapies targeting FXR and TGR5 pathways. The market for PBC drugs was valued at approximately $1.2 billion in 2022 and is growing modestly, driven primarily by unmet needs in patients intolerant to current options. The potential for seladelpar lysine depends heavily on its differentiation, efficacy, and safety profile.

Patent Protection and Market Exclusivity

Patent protection designed to expire around 2030 provides a window for commercialization. If approved, exclusivity periods could extend through data exclusivity or new formulation patents. The legal landscape influences pricing strategies and market penetration.

Revenue Projections

Assuming successful Phase 3 outcomes and FDA approval in 2025, initial peak sales are projected at $300 million annually across North America and Europe. Market adoption depends on pricing, reimbursement, and physician acceptance. Competition from other PPARδ agonists or combination therapies may suppress potential revenue.

Pricing and Reimbursement Factors

Pricing strategies will consider existing PBC treatments priced between $25,000 and $45,000 per patient annually. Reimbursement status from CMS and private insurers will affect market penetration. Cost-effectiveness analyses will determine formulary placement.

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What Is the Financial Trajectory for Seladelpar Lysine?

Projected financial performance hinges on clinical success, approval timing, market uptake, and competitive pressures.

Cost Structure and Investment

Development costs for Phase 3 trials are estimated at $150 million to $200 million, including trial management, data analysis, and regulatory submission. Upfront licensing fees or milestone payments could influence cash flow.

Revenue Timing and Sales Phases

• 2025: Expected FDA approval. Market entry allows for initial sales, assuming positive trial outcomes and regulatory clearance.
• 2026-2028: Growth phase driven by physician adoption, formulary inclusion, and reimbursement agreements.
• Post-2028: Peak sales possible by 2030, contingent on market share capture and competition.

Market Penetration and Share

Early adopters and centers of excellence are critical to market share gains. Assuming a modest 10% penetration of eligible PBC patients, sales estimates range from $70 million to $120 million annually within five years of launch. Broader uptake depends on safety profile, dosing convenience, and comparative efficacy.

Risks and Upside Potential

Key risks include failure to achieve primary endpoints, delays in regulatory review, and competitive entrants. An approval with a superior safety profile or unique mechanism could accelerate uptake, boosting sales.

• Downside risk: A clinical failure or safety concerns could delay or eliminate commercialization, resulting in sunk costs.
• Upside potential: Strategic partnerships with large pharma can accelerate market access and distribution.

Valuation Implications

Investors valuing seladelpar lysine would consider discounted cash flow models based on projected sales, growth rate assumptions (5-15% CAGR post-launch), and risk factors. A successful launch could justify valuation multiples ranging from 4x to 8x on estimated future revenues.

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Key Takeaways

• Seladelpar lysine remains in late-stage clinical trials for PBC with potential for approval by 2025.
• Market entry depends on positive efficacy and safety data, regulatory clearance, and differentiated positioning.
• The current PBC drug market was valued at $1.2 billion in 2022 and is moderately competitive.
• Projected peak sales could reach $300 million annually, assuming successful commercialization.
• Development and regulatory risks, along with competitive pressures, significantly influence financial outcomes.

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FAQs

1. What are the main competitors to seladelpar lysine?
Existing treatments like ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) are primary competitors. Newer agents targeting similar pathways or combination therapies may also compete if they demonstrate superior efficacy or safety.

2. What factors influence seladelpar lysine’s market approval?
Efficacy in reducing liver inflammation markers, safety profile, and trial endpoints are critical. Regulatory agencies require consistent demonstration of benefit with acceptable safety.

3. How does patent expiry affect seladelpar lysine’s market potential?
Patent protection until around 2030 offers a window for market exclusivity, enabling premium pricing and market share capture before generics enter.

4. What pricing strategies are expected for seladelpar lysine?
Pricing will likely align with existing PBC therapies, ranging $25,000–$45,000 per patient annually, subject to payor negotiations and value demonstration.

5. How do clinical trial delays impact the financial trajectory?
Delays postpone revenue, increase development costs, and reduce the economic attractiveness for investors. They also diminish the window for market exclusivity.

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References

[1] IBISWorld. "Primary Biliary Cholangitis Market Report," 2022.
[2] EvaluatePharma. "Pharmaceutical R&D and Market Data," 2023.
[3] ClinicalTrials.gov. "Seladelpar Clinical Trials Data," 2023.