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ZILBRYSQ Drug Patent Profile

Which patents cover Zilbrysq, and what generic alternatives are available?

Zilbrysq is a drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and thirty-four patent family members in thirty countries.

The generic ingredient in ZILBRYSQ is zilucoplan sodium. One supplier is listed for this compound. Additional details are available on the zilucoplan sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Zilbrysq

Zilbrysq will be eligible for patent challenges on October 17, 2027. 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 October 17, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZILBRYSQ

International Patents:	134
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ZILBRYSQ
What excipients (inactive ingredients) are in ZILBRYSQ?	ZILBRYSQ excipients list
DailyMed Link:	ZILBRYSQ at DailyMed

See drug prices for ZILBRYSQ

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

Constraining patent/regulatory exclusivity:

TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE

NDA:

216834

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Pharmacology for ZILBRYSQ

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for ZILBRYSQ

ZILBRYSQ is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE.

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
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes	10,835,574		Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes	11,965,040		Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-001	Oct 17, 2023		RX	Yes	Yes	11,752,190		Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	11,535,650		Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes	11,014,965			Y

International Patents for ZILBRYSQ

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

Country	Patent Number	Title	Estimated Expiration
Poland	3628680
Croatia	P20230182
South Africa	201706379	MODULATION OF COMPLEMENT ACTIVITY
South Korea	20180094913	보체 활성의 조절인자
Japan	2019504012	補体活性のモジュレーター
Australia	2016370210	Modulators of complement activity
New Zealand	727420	Modulation of complement activity

Supplementary Protection Certificates for ZILBRYSQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3154561	17/2024	Austria		PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 (MITTEILUNG) 20231204
3154561	301275	Netherlands		PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 20231204
3154561	PA2024514	Lithuania		PRODUCT NAME: ZILUKOPLANAS; REGISTRATION NO/DATE: EU/1/23/1764 20231201
3154561	CA 2024 00021	Denmark		PRODUCT NAME: ZILUCOPLAN; REG. NO/DATE: EU/1/23/1764 20231204
3154561	2024C/518	Belgium		PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204
3154561	LUC00343	Luxembourg		PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204

ZILBRYSQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZILBRYSQ

Introduction

UCB, a global biopharmaceutical company, has been on a growth path driven by its robust portfolio of innovative medicines. One of the recent additions to this portfolio is ZILBRYSQ, a drug that has been making significant strides in the market. Here, we will delve into the market dynamics and financial trajectory of ZILBRYSQ.

Launch and Global Expansion

ZILBRYSQ was launched globally starting from the first quarter of 2024. This launch is part of UCB's strategic plan to expand its presence in various therapeutic areas and geographies[3].

Initial Performance

In the first half of 2024, ZILBRYSQ generated €15 million in net sales, marking a promising start for this newly launched drug. This performance is part of the broader success of UCB's growth drivers, which include other drugs like BIMZELX®, RYSTIGGO®, and FINTEPLA®[4].

Market Positioning

ZILBRYSQ is positioned to address specific patient needs, aligning with UCB's commitment to providing innovative treatments. The drug's launch is supported by UCB's extensive global network and strategic marketing efforts, which are crucial for its market penetration and adoption.

Competitive Landscape

The pharmaceutical market is highly competitive, with numerous players vying for market share. However, UCB's strong product portfolio and the unique value proposition of ZILBRYSQ help it stand out. The drug's performance is also bolstered by the stable and growing sales of other UCB products like CIMZIA®, BRIVIACT®, and EVENITY®[2].

Financial Impact

The financial impact of ZILBRYSQ, although modest in the initial phase, is expected to grow as the drug gains more traction in the market. The overall revenue for UCB in the first half of 2024 was €2.79 billion, with net sales increasing by 11% (+13% CER), driven in part by the new launches including ZILBRYSQ[4].

Revenue Projections

For 2024, UCB projects revenue to grow towards the top end of the range of €5.5-€5.7 billion, with ZILBRYSQ contributing to this growth alongside other key products. The strong performance of these growth drivers is expected to offset any declines due to the loss of exclusivity for other products[3].

Underlying Profitability

UCB's underlying profitability, measured by adjusted EBITDA, has been robust despite higher operating expenses related to the launches of new products. In 2023, adjusted EBITDA reached €1.35 billion, and this trend is expected to continue in 2024, supported by the growing contributions from ZILBRYSQ and other new launches[2].

Cost Management and Investments

UCB's ability to manage costs effectively has been a key factor in its financial performance. The company continues to invest in product launches and clinical development programs, which includes the ongoing support for ZILBRYSQ. These investments are expected to yield long-term benefits and drive sustained growth[3].

Clinical Development and Future Growth

UCB is committed to innovation, with several clinical development programs underway. The company is studying potential medicines for 10 patient populations in 12 clinical development programs, with expected news flow in 2024. This pipeline of innovative treatments, including any future developments related to ZILBRYSQ, will be crucial for UCB's continued growth[3].

Environmental and Social Responsibility

UCB's growth strategy is also aligned with its commitment to environmental and social responsibility. The company aims to reach net zero emissions and continues to improve its ESG ratings, reflecting its efforts to create value for all stakeholders. This holistic approach supports the long-term sustainability of its business, including the success of ZILBRYSQ[2].

Key Takeaways

• Global Launch: ZILBRYSQ was launched globally in Q1 2024.
• Initial Sales: Generated €15 million in net sales in the first half of 2024.
• Market Positioning: Positioned to address specific patient needs, supported by UCB's global network.
• Financial Impact: Expected to contribute to UCB's revenue growth towards €5.5-€5.7 billion in 2024.
• Underlying Profitability: Supported by robust adjusted EBITDA performance.
• Future Growth: Part of UCB's broader innovation pipeline and growth strategy.

FAQs

Q: What is ZILBRYSQ, and when was it launched? A: ZILBRYSQ is a newly launched drug by UCB, introduced globally starting from the first quarter of 2024.

Q: How has ZILBRYSQ performed in its initial phase? A: In the first half of 2024, ZILBRYSQ generated €15 million in net sales, marking a promising start.

Q: What is the competitive landscape for ZILBRYSQ? A: The pharmaceutical market is highly competitive, but UCB's strong product portfolio and the unique value proposition of ZILBRYSQ help it stand out.

Q: How does ZILBRYSQ contribute to UCB's financial performance? A: ZILBRYSQ is expected to contribute to UCB's revenue growth towards the top end of the range of €5.5-€5.7 billion in 2024.

Q: What are UCB's future plans for ZILBRYSQ and other growth drivers? A: UCB plans to continue investing in product launches and clinical development programs, with expected news flow in 2024, driving long-term growth.

Sources

1. UCB on Growth Path for a Decade Plus - UCB USA News
2. UCB on Growth Path for a Decade Plus - PR Newswire
3. UCB on Growth Path for a Decade Plus - UCB Newsroom
4. Strong Start into UCB's Decade of Growth - UCB Newsroom