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Last Updated: December 23, 2024

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ZILBRYSQ Drug Patent Profile


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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

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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
Drug patent expirations by year for ZILBRYSQ
Drug Prices for ZILBRYSQ

See drug prices for ZILBRYSQ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZILBRYSQ
Generic Entry 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:
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 ClassComplement Inhibitor
Mechanism of ActionComplement Inhibitors

US Patents and Regulatory Information for ZILBRYSQ

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZILBRYSQ is ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-003 Oct 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-003 Oct 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-003 Oct 17, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZILBRYSQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3154561 17/2024 Austria ⤷  Subscribe PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 (MITTEILUNG) 20231204
3154561 301275 Netherlands ⤷  Subscribe PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 20231204
3154561 PA2024514 Lithuania ⤷  Subscribe PRODUCT NAME: ZILUKOPLANAS; REGISTRATION NO/DATE: EU/1/23/1764 20231201
3154561 CA 2024 00021 Denmark ⤷  Subscribe PRODUCT NAME: ZILUCOPLAN; REG. NO/DATE: EU/1/23/1764 20231204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.