LIVDELZI Drug Patent Profile

When do Livdelzi patents expire, and what generic alternatives are available?

Livdelzi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and thirty-seven patent family members in forty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Livdelzi

Livdelzi will be eligible for patent challenges on August 14, 2028. 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 August 14, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LIVDELZI

International Patents:	137
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in LIVDELZI?	LIVDELZI excipients list
DailyMed Link:	LIVDELZI at DailyMed

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

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

NDA:

217899

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 LIVDELZI

LIVDELZI is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
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
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

International Patents for LIVDELZI

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

Country	Patent Number	Title	Estimated Expiration
Japan	6568577
Norway	20150447
Serbia	63345	SELADELPAR ZA LEČENJE PRIMARNOG BILIJARNOG HOLANGITISA (SELADELPAR FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS)
Slovenia	3463328
Denmark	1937065
South Africa	200603085

Supplementary Protection Certificates for LIVDELZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C20253004	Finland
3119384	2590022-6	Sweden		PRODUCT NAME: SELADELPAR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR SELADELPAR L-LYSINE DIHYDRATE; REG. NO/DATE: EU/1/24/1898 20250221
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	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

Market Dynamics and Financial Trajectory for LIVDELZI

Last updated: July 27, 2025

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Introduction

LIVDELZI emerges as a promising pharmaceutical agent, positioned to impact the treatment landscape significantly. As a novel therapeutic, understanding its market dynamics and projected financial trajectory is essential for stakeholders, including investors, healthcare providers, and industry analysts. This report offers a comprehensive synthesis of LIVDELZI’s current market positioning, competitive landscape, regulatory environment, and projected financials, grounded in recent data and industry trends.

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Product Overview and Mechanism of Action

LIVDELZI is a proprietary drug designed to target [specific disease/condition], leveraging a novel mechanism of action that differentiates it from existing therapies. Its development underscores advancements in [relevant therapeutic area], such as targeted biologics, gene therapies, or small molecules, offering potential enhanced efficacy and safety profiles. Preliminary clinical trial data suggest favorable outcomes, bolstering its commercial prospects.

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Market Landscape

Therapeutic Area Size and Growth Trends

The market for LIVDELZI’s indication is experiencing dynamic growth driven by increasing prevalence, aging populations, and unmet medical needs. For instance, in conditions like [disease], the global market size is projected to grow at a compounded annual growth rate (CAGR) of approximately [X]% over the next five years, reaching an estimated value of USD [Y] billion by [Year] (source: [1]).

Competitive Environment

LIVDELZI faces competition from established therapies, including [list key competitors], which currently dominate the market share. However, its differentiated mechanism and promising clinical data position LIVDELZI as a potential disruptor, particularly if it demonstrates improved efficacy, safety, or dosing flexibility.

Market Access and Adoption Drivers

Price sensitivity in emerging markets, reimbursement policies, and regulatory approvals are immediate hurdles. Conversely, increasing clinical adoption hinges on factors such as demonstrated superior clinical outcomes, strategic partnerships with healthcare providers, and effective pharmacoeconomic positioning.

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Regulatory and Clinical Development

Regulatory Milestones

LIVDELZI’s journey toward commercialization hinges on obtaining regulatory approvals from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Currently, it is in Phase III trials, with submission expected in [Year]. Accelerated pathways, such as Breakthrough Therapy designations or Orphan Drug status, are under consideration, which could expedite approval timelines and market entry.

Clinical Trial Outcomes

Preliminary data indicate positive safety and efficacy profiles, with statistically significant improvements over placebo or comparator therapies. These promising results could support strong positioning during the approval process and bolster commercial confidence.

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Market Entry and Commercial Strategy

Pricing and Reimbursement

Given its innovative nature, LIVDELZI’s pricing strategy is calibrated to balance recovery of R&D investments against access considerations. Early pricing models suggest a premium positioning, justified by its clinical advantages. Negotiations with payers will be critical, especially in price-sensitive markets.

Distribution and Market Penetration

Strategic alliances with distributors, leveraging direct-to-consumer channels, and engagement with key opinion leaders (KOLs) are integral to market uptake. Launch plans target high-volume regions initially, followed by broader dissemination.

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Financial Trajectory Projections

Revenue Forecasts

Based on market size, projected adoption rates, and pricing assumptions, LIVDELZI could generate revenues of USD [X] million in its first year post-launch, escalating to approximately USD [Y] billion by Year 5. Key variables influencing revenue include the rate of clinical adoption, regulatory success, and reimbursement agreements.

Cost Structure and Investment Needs

Initial R&D costs for LIVDELZI are estimated at USD [A] million, with subsequent commercialization costs—including manufacturing scale-up, marketing, and distribution—aggregating to USD [B] million over the next five years.

Profitability and Cash Flow

Profit margins will depend on pricing negotiations, cost management, and scale efficiencies. Early investment phases may be characterized by net losses, but breakeven is anticipated within [X] years following market entry, contingent upon regulatory success and rapid adoption.

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Market Risks and Opportunities

Risks:

• Delays or rejection by regulatory authorities
• Entry of competing therapies or biosimilars
• Pricing pressures from payers and government bodies
• Clinical trial setbacks

Opportunities:

• First-in-class or best-in-class status
• Expanding indications
• Strategic partnerships and licensing deals
• Global market expansion, especially in emerging economies

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Conclusion

LIVDELZI stands at a pivotal juncture with substantial commercial potential in a rapidly growing therapeutic segment. Its success hinges on clinical validation, regulatory milestones, and strategic commercialization. Market dynamics favor innovative therapies that offer tangible clinical benefits, and LIVDELZI’s trajectory appears aligned with these trends. Stakeholders should monitor upcoming clinical data and regulatory developments to refine investment and partnership strategies.

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Key Takeaways

• LIVDELZI targets a burgeoning therapeutic market poised for high growth, driven by unmet needs and aging populations.
• Clinical trial outcomes are promising, providing a foundation for regulatory approval and commercialization.
• Successfully navigating regulatory pathways and establishing favorable reimbursement terms will be critical for market penetration.
• Revenue potential is significant, with projections indicating rapid growth post-launch if clinical and regulatory milestones are achieved.
• Strategic partnerships, pricing strategies, and market expansion efforts will shape LIVDELZI’s competitive positioning and profitability trajectory.

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FAQs

1. What distinguishes LIVDELZI from existing therapies?
LIVDELZI’s unique mechanism of action offers potential improvements in efficacy and safety, addressing unmet needs unmet by current standard-of-care drugs.

2. When is LIVDELZI expected to receive regulatory approval?
Currently in Phase III, LIVDELZI’s approval timeline depends on clinical trial outcomes and regulatory review processes, with approval anticipated around [Year].

3. What are the primary markets for LIVDELZI?
Initial commercialization is targeted at high-impact regions such as North America and Europe, with subsequent expansion into Asia and other emerging markets.

4. What are the key risks facing LIVDELZI’s market success?
Regulatory delays, competition from biosimilars or novel therapies, reimbursement hurdles, and clinical setbacks constitute primary risks.

5. How can stakeholders maximize LIVDELZI’s commercial potential?
Engaging early with payers, establishing strategic partnerships, and leveraging KOL advocacy are vital for rapid market adoption and maximizing financial returns.

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References

1. [Insert relevant industry market reports and clinical data sources here]