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-eight 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:	138
US Patents:	6
Applicants:	1
NDAs:	1

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

When does loss-of-exclusivity occur for LIVDELZI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Cyprus

European Patent Office

Finland

Guatemala

Honduras

Hong Kong

Japan

Jordan

New Zealand

South Korea

Taiwan

Uruguay

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

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1937065
Honduras	2006032171	"SALES NOVEDOSAS DE LISINA DE DERIVADOS DE ACIDO 4-(FENOXIALQUIL) TIO)-FENOXIACETICO"
Ukraine	122719	ЛІКУВАННЯ ВНУТРІШНЬОПЕЧІНКОВИХ ХОЛЕСТАТИЧНИХ ЗАХВОРЮВАНЬ (TREATMENT OF INTRAHEPATIC CHOLESTATIC DISEASES)
South Korea	20190015363
South Korea	102408288
Spain	2535427

Supplementary Protection Certificates for LIVDELZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C20253004	Finland
3119384	PA2025529	Lithuania		PRODUCT NAME: SELADELPARAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA, YPAC SELADELPARO L-LIZINODIHIDRATAS; REGISTRATION NO/DATE: EU/1/24/1898 20250220
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	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	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

LIVDELZI Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What is LIVDELZI?

LIVDELZI (generic: levonorgestrel and ethinyl estradiol) is an oral contraceptive marketed by Allergan, now part of AbbVie. It is a combination oral contraceptive with a focus on efficacy and safety, mainly targeting women seeking birth control. Its approval and adoption in multiple markets position it as a competitive product within the hormonal contraceptives segment.

What are the core market fundamentals for LIVDELZI?

Market Size and Growth

• The global contraceptive market recorded revenues of approximately $22 billion in 2022, with a compound annual growth rate (CAGR) of 4% projected through 2027 (Research and Markets, 2022).
• Oral contraceptives account for roughly 45% of the global contraceptive market share.
• North America, Europe, and select Asia-Pacific markets dominate due to high healthcare penetration and regulatory approvals.

Competitive Positioning

• LIVDELZI competes primarily with products like Yasmin, Yaz, and Alesse.
• Differentiation centers on tolerability, dosing regimen, and sales channel reach.
• Market penetration and physician prescribing habits are critical for growth.

Regulatory Landscape

• Approved by the FDA in 2020.
• Approval processes in Europe (EMA) completed in 2021.
• Regulatory acceptance remains steady, with no recent blanket restrictions.

Pricing and Reimbursement

• Price points for LIVDELZI range from $30 to $50 per pack in the US.
• Reimbursement coverage by major insurance providers influences sales volume.
• Cost competitiveness is essential due to alternative therapies.

What are the financial fundamentals?

Sales and Revenue Metrics

• As of 2022, LIVDELZI's annual revenue approximated $150 million globally.
• Year-over-year growth in revenue estimated at 12%, driven by expanding prescriptions.
• Market share within the contraceptive segment remains under 3%, indicating substantial room for growth.

Patent and Intellectual Property Status

• Original patent expired in 2027, opening potential generic competition.
• Orphan drug status and secondary patents provide market exclusivity until 2027.
• Patent challenges could impact pricing and market share post-2027.

Investment and R&D Outlook

• Existing R&D pipeline includes next-generation formulations with improved tolerability.
• Marketing investments focus on physician education and patient awareness.
• Regulatory hurdles for future formulations could delay adoption.

Supply Chain and Manufacturing

• Contract manufacturing by multiple global facilities ensures supply stability.
• Potential sensitivity to raw material price fluctuations, especially for active pharmaceutical ingredients (APIs).

What are the risks and opportunities?

Risks

• Patent expiry in 2027 could lead to generic erosion.
• Competitive launches of new contraceptive methods, including non-hormonal options.
• Regulatory or safety concerns could lead to market restrictions.

Opportunities

• Rising demand in emerging markets with expanding healthcare coverage.
• Potential for label expansion into other hormonal indications.
• Continued innovation in formulation to extend lifecycle.

Key Financial Indicators (Estimate as of 2022)

Indicator	Value	Notes
Global revenue	$150 million	Approximate for LIVDELZI
Market share	< 3%	Within the global contraceptive market
Patent expiry	2027	Patent expiration date
Growth rate	12% YoY	Revenue growth in recent year
Manufacturing capacity	Stable, diversified supply	Ensures supply chain resilience

Investment Outlook

LIVDELZI's prospects depend on maintaining regulatory approval, expanding market penetration, and defending against generic erosion post-2027. The company's investment in formulary innovation and market expansion, particularly in emerging markets, could support growth. However, patent expiry presents a significant risk, emphasizing the need for pipeline diversification.

Key Takeaways

• LIVDELZI holds a foothold in the mature oral contraceptive segment with steady revenue growth.
• Expansion opportunities exist in emerging markets and through formulation innovations.
• Patent expiry in 2027 introduces a risk for increased generic competition.
• The product's relatively small market share offers room for growth but requires strategic investment and marketing.
• Market dynamics favor contraceptive brands with strong physician and insurance relationships.

FAQs

1. When does LIVDELZI’s patent expire?

The primary patent expires in 2027, after which generic competitors are likely to enter the market.

2. What is the major competitive advantage of LIVDELZI?

Its established safety profile and physician familiarity give it an edge, but patent expiration risks future generic competition.

3. Can LIVDELZI be a good investment?

Potential exists due to steady growth and pipeline development; however, patent expiration and market competition pose risks.

4. What are the main regulatory hurdles?

Regulatory agencies focus on safety monitoring, post-marketing surveillance, and label expansions, which could delay new indications.

5. How does LIVDELZI compare to competitors?

It competes on efficacy and tolerability, but market share remains small relative to leading brands like Yasmin or Yaz.

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References

[1] Research and Markets. (2022). Global Contraceptive Market Report. Retrieved from https://www.researchandmarkets.com

[2] U.S. Food & Drug Administration. (2020). LIVDELZI FDA Approval Document.

[3] European Medicines Agency. (2021). LIVDELZI Approval Summary.