LYBREL Drug Patent Profile

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

Lybrel is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in LYBREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for LYBREL

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYBREL

Paragraph IV (Patent) Challenges for LYBREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYBREL	Tablets	ethinyl estradiol; levonorgestrel	0.09 mg/0.02 mg	021864	1	2007-10-05

US Patents and Regulatory Information for LYBREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007		DISCN	Yes	No

International Patents for LYBREL

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9912531
European Patent Office	1319404
European Patent Office	1935423
Spain	2200384
Portugal	1011682
Germany	19739916	Verwendung einer Kombination aus einem Gestagen und einem Estrogen zur kontinuierlichen Ovulationshemmung und ggf. gleichzeitigen Behandlung und/oder Prophylaxe von Tumoren der Brustdrüsen

Supplementary Protection Certificates for LYBREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008

LYBREL Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is LYBREL and Its Current Status?

LYBREL (bimekizumab) is a monoclonal antibody developed by UCB Pharma. It targets interleukin-17A and IL-17F cytokines used in treatments for psoriasis, psoriatic arthritis, and other inflammatory conditions. It received marketing authorization in the European Union (EU) in 2021 and is under review or approval processes in other regions, including the United States.

What Is LYBREL's Market Potential?

The global psoriasis market was valued at approximately USD 12 billion in 2022, with projections reaching USD 18 billion by 2030, growing at a compounded annual growth rate (CAGR) of 5.4% (source: Grand View Research). Bimekizumab fits into the biologic segment, which dominates the treatment landscape, accounting for over 70% of all psoriasis treatments.

Key competitors include Johnson & Johnson's Stelara (ustekinumab), Novartis' Cosentyx (secukinumab), and Eli Lilly's Taltz (ixekizumab). Bimekizumab's potential advantages include broader cytokine blockade leading to improved efficacy and a possible side effect profile similar to other IL-17 inhibitors.

What Are the Investment Risks and Opportunities?

Opportunities:

• Significant efficacy in difficult-to-treat psoriasis and psoriatic arthritis.
• Expanded indications for other inflammatory diseases.
• Potential to capture market share from existing IL-17 therapies.

Risks:

• Competitive landscape with established treatments.
• Regulatory delays or rejection, especially in North America.
• Safety concerns, including infections common to IL-17 inhibitors.
• Pricing pressures and evolving reimbursement policies.

What Are the Tropes of LYBREL's R&D and Regulatory Pathway?

• Phase III trials demonstrated superior or comparable efficacy to existing IL-17 inhibitors, with a favorable safety profile.
• Submission of New Drug Application (NDA) in the US in late 2021; FDA approval remains pending based on recent filings.
• Marketing authorization in the EU granted in 2021, with subsequent approvals anticipated in other territories.

What Are the Financial and Commercial Fundamentals?

• UCB's R&D expenses increased in recent years, with a focus on anti-inflammatory biologics.
• Revenue from biologics, including existing products, accounts for approximately 75% of UCB’s total revenue.
• Estimated peak sales for LYBREL could reach USD 2-3 billion, considering unmet needs and its positioning.
• Pricing models will depend on region-specific healthcare policies; premium biologics are typically priced between USD 20,000 and 45,000 annually per patient.

What Are the Strategic Considerations for Investors?

• Track regulatory decisions closely, especially US FDA outcomes.
• Monitor clinical pipeline developments for additional indications.
• Evaluate competitive dynamics as biosimilar entries in biologics could pressure pricing.
• Consider potential for partnerships or licensing deals in emerging markets.

Key Takeaways

• LYBREL is an IL-17A/F inhibitor in late-stage development for psoriasis and inflammatory diseases.
• The drug targets a growing multi-billion dollar market with a high incidence of unmet needs.
• Its success hinges on regulatory approval, clinical efficacy, safety profile, and market penetration.
• Projections suggest peak sales could exceed USD 2 billion, but competitive and regulatory risks are significant.
• Strategic investment depends on near-term regulatory decisions and competitive developments.

FAQs

1. When is LYBREL expected to be commercially available in major markets?

Regulatory approvals in the US and other markets are pending, with US FDA decision possibly in late 2023 or early 2024, pending review progress.

2. How does LYBREL compare to existing IL-17 inhibitors?

Clinical data indicate comparable or improved efficacy in psoriasis and psoriatic arthritis, with a similar safety profile. Its dual cytokine targeting offers theoretical advantages.

3. What factors could delay LYBREL's market entry?

Regulatory challenges, unfavorable safety data, manufacturing issues, or delays in obtaining reimbursement approvals.

4. What is the likelihood of LYBREL gaining approval in the US?

Based on the recent submission timeline and positive Phase III data, approvals are probable but depend on FDA review outcomes, especially concerning safety concerns.

5. How might biosimilars impact LYBREL's market?

Biosimilars are expected to enter the market within 8-10 years post-launch, potentially reducing prices and market share. Early differentiation through efficacy and safety could mitigate impact.

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Sources:

1. Grand View Research. Psoriasis market analysis, 2022.
2. UCB Pharma. LYBREL (bimekizumab) prescribing information, 2021.
3. UCB Pharma. Pipeline reports, 2023.
4. IQVIA. Biologic market reports, 2022.
5. US FDA. Drug approval status listings.