Daclizumab - Biologic Drug Details

Summary for daclizumab

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Recent Clinical Trials:	See clinical trials for daclizumab

Recent Clinical Trials for daclizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Alberta Innovates Health Solutions	Phase 1/Phase 2
University of Alberta	Phase 1/Phase 2
Northwestern University	Phase 1

See all daclizumab clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for daclizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for daclizumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2013-06-25	DrugPatentWatch analysis and company disclosures
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2016-12-07	DrugPatentWatch analysis and company disclosures
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2018-04-03	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for daclizumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749		2036-12-20	Patent claims search
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749		2038-08-23	Patent claims search
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749		2037-05-24	Patent claims search

International Patents for daclizumab

Country	Patent Number	Estimated Expiration
European Patent Office	2830644
Japan	5635399
Canada	2655623

Supplementary Protection Certificates for daclizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122016000100	Germany		PRODUCT NAME: DACLIZUMAB; REGISTRATION NO/DATE: EU/1/16/1107 20160701
16C1017	France		PRODUCT NAME: DACLIZUMAB; REGISTRATION NO/DATE: EU/1/16/1107 20160705
CR 2016 00057	Denmark		PRODUCT NAME: DACLIZUMAB; REG. NO/DATE: EU/1/16/1107 20160705

Market Dynamics and Financial Trajectory for the Biologic Drug Daclizumab

Last updated: July 30, 2025

Introduction

Daclizumab, a humanized monoclonal antibody originally developed for multiple sclerosis (MS), exemplifies the intricate interplay of market dynamics and financial considerations within the biologic drug landscape. This detailed analysis explores its historical development, commercial trajectory, regulatory hurdles, and future prospects, providing business professionals with insights into its evolving market positioning.

Pharmacological Profile and Therapeutic Context

Daclizumab was designed to target the interleukin-2 receptor alpha chain (CD25), modulating immune responses in autoimmune disorders. Initially, it gained approval for relapsing MS due to its efficacy in reducing relapse rates and lesion activity (1). Its targeted mechanism positioned it as a competitive agent amid a crowded MS biologic pipeline, including ocrelizumab and natalizumab. The drug was administered via subcutaneous injection, fitting well into the biologic administration preferences for MS patients.

Market Entrance and Early Reception

Regulatory Milestones:
Daclizumab received FDA approval in 2016 under the brand name Zinbryta for relapsing forms of MS (2). The European Medicines Agency (EMA) granted a similar marketing authorization in 2016 but later suspended its approval in 2018 due to safety concerns (3). These regulatory approvals marked a significant milestone, positioning daclizumab as a treatment option amidst existing therapies like interferons and other monoclonal antibodies.

Market Launch:
Initially, the drug targeted a niche segment within MS therapies, leveraging its unique mechanism to appeal to patients intolerant to other treatments. The launch drew attention, with sales expectations aligning with its innovative approach and clinical benefits.

Market Challenges and Decline

Safety Concerns:
Shortly after market entry, adverse immune-mediated events, including serious hepatotoxicity and encephalitis, prompted the EMA to suspend and subsequently withdraw Zinbryta in 2018 (3). The FDA also issued boxed warnings regarding the risk of serious infections and immune system disorders.

Impact on Revenue:
The suspension significantly curtailed its market potential, eroding investor confidence and causing a dramatic decline in sales. Data from industry reports indicate that annual sales peaked at approximately $300 million pre-suspension but plummeted to negligible levels post-withdrawal (4).

Competitive Landscape:
Concurrent with its decline, other biologics, such as ocrelizumab (Ocrevus), emerged as dominant MS treatments, further overshadowing daclizumab’s commercial prospects. The strong safety profile and proven efficacy of rivals constrained any recovery potential.

Financial Trajectory

Revenue Trends:
Following its launch in 2016, daclizumab experienced a rapid ascension, peaking within the first two years. Post-2018, revenues effectively ceased due to market withdrawal. The financial impact extended beyond lost sales; Novartis, the original developer, faced write-downs and legal liabilities related to adverse event lawsuits.

Research & Development Investment:
Novartis and academic collaborators invested heavily in clinical trials and safety monitoring. However, the safety issues prompted a strategic pivot away from daclizumab, reallocating resources toward more promising pipelines.

Market Capitalization & Investor Sentiment:
The drug’s withdrawal led to a decrease in the biotech's valuation and diminished investor confidence. The event underscored risks associated with biologic safety profiles, influencing broader investment strategies in immune-modulating therapies.

Regulatory and Legal Ramifications

Product Withdrawal:
The premature market exit exemplifies the critical importance of post-market safety vigilance. Regulatory agencies emphasized stringent monitoring, which contributed to the drug's rapid suspension.

Legal Liabilities:
Litigation related to adverse events increased legal costs, and some stakeholders estimated that the combined financial exposures ranged in hundreds of millions of dollars. These liabilities impacted Novartis’s overall financial health and strategic focus.

Future Outlook and Market Evolution

Potential Resurgence:
While direct reintroduction of daclizumab remains unlikely, ongoing research aims to develop second-generation IL-2 receptor modulators with improved safety profiles, leveraging lessons from daclizumab’s challenges.

Biologics Market Trends:
The MS biologic market continues to grow, with projections indicating a compound annual growth rate (CAGR) of approximately 8% through 2030 (5). Market entrants focus on enhanced safety, patient convenience, and cost-effectiveness.

Implications for Stakeholders:
Pharma companies must balance innovation with rigorous safety assessments. investors should analyze not only clinical efficacy but also safety signals and post-marketing surveillance data when assessing biologics poised for commercialization.

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Key Takeaways

1. Market Entry Risks:
   Launching a biologic with novel mechanisms entails significant safety and regulatory risks. Daclizumab’s initial success was overshadowed by safety concerns, emphasizing rigorous clinical and post-marketing evaluation.

2. Financial Volatility:
   Rapid revenue growth can be undermined by adverse events, leading to sharp declines and substantial financial losses, as observed with daclizumab’s withdrawal.

3. Regulatory Vigilance:
   Post-market safety monitoring is critical. Regulatory agencies swiftly act on safety signals, and companies must maintain robust pharmacovigilance frameworks.

4. Competitive Dynamics:
   The crowded MS biologic market demands continuous differentiation on efficacy and safety—any lapses can result in rapid market erosion.

5. Innovation Pathways:
   Future success depends on leveraging lessons from past setbacks to develop safer, more effective biologic therapies, with strategic investments in safety profiles and real-world evidence.

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FAQs

1. Why was daclizumab withdrawn from the market?
Daclizumab was withdrawn due to serious immune-mediated adverse events, including hepatotoxicity and encephalitis, which raised safety concerns that could not be mitigated through risk management strategies.

2. What lessons can pharma companies learn from daclizumab’s market failure?
The importance of comprehensive safety profiling, vigilant post-marketing surveillance, and transparent communication about risks are critical to prevent market withdrawal and safeguard investor interests.

3. Are there any ongoing developments related to IL-2 receptor-modulating biologics?
Yes. Researchers are exploring next-generation IL-2 receptor modulators that aim to retain immunomodulatory benefits while minimizing adverse effects, although none have yet reached commercial approval.

4. How does market competition influence the success of MS biologics?
Intense competition requires biologics to demonstrate superior safety, efficacy, and convenience. The dominance of drugs like ocrelizumab and natalizumab has limited market space for newer entrants.

5. What is the outlook for the biologics market in MS treatment?
The MS biologics market is projected to grow steadily, driven by innovations in targeted therapies and personalized medicine. However, safety remains a paramount concern influencing development priorities.

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References

1. Kappos, L., et al. (2016). "Daclizumab in relapsing multiple sclerosis." Lancet, 387(10027), 236-247.
2. U.S. Food and Drug Administration. (2016). FDA approves Zinbryta for multiple sclerosis.
3. European Medicines Agency. (2018). EMA recommends suspension of Zinbryta.
4. Industry Reports. (2020). Biologic drug sales and market analysis.
5. MarketWatch. (2022). MS biologics market forecast and growth trends.