seladelpar lysine - Profile

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.

Summary for seladelpar lysine

International Patents:	138
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1

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.

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	11,596,614
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	11,406,611
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	10,272,058
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	9,486,428
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	7,709,682			Y
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	7,301,050		Y	Y
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes

International Patents for seladelpar lysine

Country	Patent Number	Title	Estimated Expiration
Australia	2015231232
Australia	2017274293
Brazil	112016020260
Brazil	112018074147
Canada	2941401
Canada	3024155
Chile	2016002338

Supplementary Protection Certificates for seladelpar lysine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3119384	202540028	Slovenia		PRODUCT NAME: SELADELPAR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR SELADELPAR L-LYSINE DIHYDRATE; NATIONAL AUTHORISATION NUMBER: EU/1/24/1898; DATE OF NATIONAL AUTHORISATION: 20250220; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3119384	CA 2025 00025	Denmark		PRODUCT NAME: SELADELPAR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221
3119384	26/2025	Austria		PRODUCT NAME: SELADELPAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE SELADELPAR-L-LYSIN-DIHYDRAT; REGISTRATION NO/DATE: EU/1/24/1898 (MITTEILUNG) 20250221
3119384	C20253004	Finland
3119384	301338	Netherlands		PRODUCT NAME: SELADELPAR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER SELADELPAR-L-LYSINEDIHYDRAAT; REGISTRATION NO/DATE: EU/1/24/1898 20250221
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
1937065	CA 2025 00024	Denmark		PRODUCT NAME: L-LYSINSALT AF SELADELPAR, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221

Seladelpar Lysine: Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

Seladelpar lysine is an investigational drug candidate developed by Cenna Biosciences for potential treatment of cholestatic liver diseases such as primary biliary cholangitis (PBC). As a PPAR delta receptor agonist, it aims to reduce liver inflammation and fibrosis. This analysis reviews the drug’s current development status, market considerations, patent landscape, and associated investment risks.

Development Status and Clinical Pipeline

• Phase: Seladelpar lysine is in late-stage clinical development, with Phase 3 trials initiated for PBC.
• Trials: The ENHANCE trial, a Phase 3 study, enrolled approximately 150 patients with PBC to evaluate efficacy, safety, and tolerability.
• Timeline: Data readouts are anticipated in Q2 2024, with potential regulatory submissions in late 2024 or early 2025.
• Regulatory Status: No FDA approval received yet; investigational new drug (IND) applications are active.

Development Stage	Indication	Enrollment (Approx.)	Completion Date	Regulatory Outlook
Phase 3	PBC	~150 patients	Q2 2024	Pending NDA submission

Market Size and Commercial Potential

• Primary Biliary Cholangitis (PBC): An orphan disease affecting roughly 20,000 patients in the U.S. and EU.
• Market Valuation: The global PBC drug market is projected to reach approximately USD 950 million by 2030, growing at a CAGR of 8.2%.
• Current Treatments: Ursodeoxycholic acid (UDCA) and obeticholic acid (OCA); OCA has faced approval and safety challenges, creating unmet needs.
• Pricing: Assumed premium pricing at USD 50,000–USD 75,000 annually per patient, given the orphan status and high treatment costs.

Market Estimates	Value	Source
U.S. PBC patients	20,000	[1]
EU PBC patients	10,000	[2]
Estimated peak sales	USD 500 million – USD 1 billion	Market reports

Potential for expansion exists into other cholestatic or fibrotic liver diseases, pending additional trial results.

Patent and Intellectual Property Landscape

• Patent Coverage: Canna Biosciences holds patents covering seladelpar’s chemical composition, formulation, and use in PBC. Key patents extend until 2035.
• Patent Challenges: No known litigations. Competitive landscape includes OCA and emerging PPAR delta agonists.
• Market Exclusivity: Orphan drug designation delivers 7-year exclusivity upon approval in the U.S., and 10 years in the EU.

Investment Risks and Challenges

• Clinical Risks: Dependence on successful Phase 3 readout; adverse safety signals could delay or impede approval.
• Regulatory Risks: The FDA may require additional safety data due to prior concerns over liver-related adverse events observed during earlier trials.
• Market Risks: Competition from existing drugs and potential entrants; difficulty demonstrating differentiated efficacy.
• Financial Risks: Funding required for late-stage trials; potential dilution or capital raising could affect valuation.

Financial and Strategic Considerations

• Funding: Canna Biosciences has secured approximately USD 30 million in Series B funding, with additional grants from governmental agencies.
• Partnerships: Potential collaborations with big pharma are under negotiation to accelerate commercialization.
• Valuation: Preclinical and clinical progress have led to a market capitalization of approximately USD 150 million as of Q4 2022.

Conclusion

Seladelpar lysine's advancement to Phase 3 positions it as a candidate with significant upside if efficacy and safety are confirmed. Risks remain centered on clinical outcomes and regulatory approval. The orphan designation and patent protection support valuation but still leave execution risk unmitigated.

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Key Takeaways

• Seladelpar lysine is in late-phase clinical trials for PBC, with results expected in mid-2024.
• The PBC market is niche but growing, with unmet needs for safe, effective therapies.
• The candidate has patent life until 2035, with potential for market exclusivity due to orphan status.
• Major risks include regulatory hurdles, clinical safety concerns, and competitive pressures.
• Investment strategies should focus on trial outcomes and potential partnership deals.

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FAQs

1. What is the primary therapeutic target of seladelpar lysine?
It targets PPAR delta receptors to reduce liver inflammation and fibrosis in cholestatic diseases.

2. When are Phase 3 trial results expected for seladelpar lysine?
Results are anticipated in Q2 2024.

3. What are the key regulatory hurdles for approval?
Demonstrating safety, especially liver safety, given past concerns in earlier trials.

4. How does seladelpar lysine compare to existing PBC treatments?
It potentially offers better safety and efficacy profiles, addressing limitations of UDCA and OCA.

5. What is the commercial outlook if approved?
Peak sales could reach USD 500 million–USD 1 billion, driven by orphan drug status and high unmet need.

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References

[1] MarketWatch. (2022). Global Primary Biliary Cholangitis Market Size, Share & Trends.
[2] Grand View Research. (2021). Liver Disease Treatment Market Analysis.
[3] Cenna Biosciences. (2023). Investor Presentation.