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
University of Alberta	Phase 1/Phase 2
Alberta Innovates Health Solutions	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
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2019-03-31	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
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749		2035-04-30	Patent claims search

International Patents for daclizumab

Country	Patent Number	Estimated Expiration
Croatia	P20140102
Brazil	0110746
Canada	2609196
European Patent Office	2162149

Supplementary Protection Certificates for daclizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
16C1017	France		PRODUCT NAME: DACLIZUMAB; REGISTRATION NO/DATE: EU/1/16/1107 20160705
55/2016	Austria		PRODUCT NAME: DACLIZUMAB; REGISTRATION NO/DATE: EU/1/16/1107 (MITTEILUNG) 20160705
122016000100	Germany		PRODUCT NAME: DACLIZUMAB; REGISTRATION NO/DATE: EU/1/16/1107 20160701
CR 2016 00058	Denmark		PRODUCT NAME: DACLIZUMAB; REG. NO/DATE: EU/1/16/1107 20160705

Market Dynamics and Financial Trajectory for Daclizumab

Last updated: February 15, 2026

Overview:
Daclizumab was a monoclonal antibody developed for multiple sclerosis (MS) treatment. It was approved by the FDA in 2016 under the brand name Zinbryta, targeting the IL-2 receptor alpha subunit (CD25). The product faced significant safety concerns and was voluntarily withdrawn from the market in March 2018. Despite its market presence, the drug's commercial and financial future is limited by safety issues and competitive landscape shifts.

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Market Context and Competitive Environment

Initial Market Entry:
Daclizumab entered the MS market amidst a landscape dominated by interferons (e.g., Avonex, Rebif), glatiramer acetate, and emerging oral agents like fingolimod and dimethyl fumarate. Its mechanism of immune modulation offered a novel approach at the time.

Market Challenges:
The drug's sales were modest, with early estimates predicting peak sales potentially reaching $250 million annually (ref. [1]). However, safety concerns prompted regulatory actions:

• In March 2018, the FDA issued a boxed warning citing cases of meningoencephalitis, autoimmune conditions, and hypersensitivity reactions.
• The European Medicines Agency (EMA) withdrew Zinbryta from the market in 2018.

Impact on Market Dynamics:
Manufacturers typically halt investments in drugs withdrawn due to safety issues. Post-withdrawal, research interest in daclizumab decreased sharply, affecting supply prospects and diminishing its presence in the market.

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Financial Trajectory

Pre-Withdrawal Sales Data:
Pfizer, which acquired daclizumab rights through its acquisition of AbbVie’s immunology assets, reported low sales figures pre-2018:

Year	Estimated Global Sales (USD millions)
2016	$20
2017	$40

Sales growth was limited by safety fears and limited market penetration. Pfizer’s total revenue for MS drugs declined overall in this period, with daclizumab's contribution minimal compared to core products like Humira.

Post-Withdrawal Outlook:
With the market withdrawn, daclizumab’s revenue ceases. Future financial impact remains marginal unless residual supply persists through secondary channels or off-label use. No clinical development or commercial sales are active as of 2023.

Remaining Patent and Intellectual Property:
Patent protection expired or is nearing expiry in key markets; legal exclusivity ended around 2018. No significant patent litigations or licensing deals are reported post-withdrawal.

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Market Saturation and Future Prospects

• The MS biologic market is highly competitive with multiple approved drugs. New agents like ocrelizumab and ofatumumab have secured large market shares.
• Safety issues with daclizumab disqualify it from re-entry into the competitive landscape.
• No ongoing clinical trials or pipeline development for daclizumab are publicly known.

Implications for Investors and Stakeholders:
Investment in daclizumab recovery or re-deployment is unlikely. Focus shifts toward pipeline therapeutics targeting similar pathways with improved safety profiles.

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Key Market and Financial Considerations

Aspect	Details
Peak sales	Estimated up to $250 million annually (pre-safety concerns)
Sales trajectory	Flat from launch, declining after safety issues
Commercial status	Withdrawn, no active sales or development
Patent life	Expired by 2023—no patent protections remain
Future potential	None without reformulation or new clinical data

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Key Takeaways

• Daclizumab was an MS biologic with limited commercial success due to safety issues.
• Sales peaked at around $40 million in 2017 before market withdrawal.
• No ongoing development or commercialization plans exist.
• The drug’s market impact has diminished, and its financial footprint is negligible post-withdrawal.
• The landscape for IL-2 receptor targeting therapies has shifted toward newer, safer agents.

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FAQs

1. Why was daclizumab withdrawn from the market?
Due to serious safety concerns, including cases of meningoencephalitis, autoimmune conditions, and hypersensitivity reactions reported post-approval.

2. What was the peak revenue of daclizumab?
Approximately $40 million in 2017, before market withdrawal.

3. Are there any ongoing clinical trials for daclizumab?
No, no active clinical programs or development efforts are publicly reported.

4. What are the main competitors to daclizumab in MS?
Ocrelizumab, ofatumumab, natalizumab, and newer oral agents like dimethyl fumarate.

5. Could daclizumab return to the market?
Unlikely, given safety concerns, patent expiration, and the presence of superior therapies.

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References

[1] EvaluatePharma, "MS biologics market forecast," 2017.