ZINBRYTA Drug Profile

Summary for Tradename: ZINBRYTA

High Confidence Patents:	15
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ZINBRYTA

Recent Clinical Trials for ZINBRYTA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
AbbVie	Phase 3
Biogen	Phase 3
Hammersmith Hospitals NHS Trust	Phase 4

See all ZINBRYTA 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 company disclosures

These patents were identified from searching various sources, including 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 ZINBRYTA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ZINBRYTA 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	5,530,101	2013-06-25	DrugPatentWatch analysis and company disclosures
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	5,997,867	2016-12-07	DrugPatentWatch analysis and company disclosures
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	6,171,587	2018-04-03	DrugPatentWatch analysis and company disclosures
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	6,194,551	2019-03-31	DrugPatentWatch analysis and company disclosures
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	6,551,592	2017-09-03	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ZINBRYTA 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
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	10,016,338	2036-12-20	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	10,064,938	2037-03-13	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	10,085,955	2034-01-08	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	10,086,046	2037-02-22	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	10,111,968	2036-08-10	Patent claims search

International Patents for ZINBRYTA

Country	Patent Number	Estimated Expiration
Germany	60128084
Brazil	112013001107
Japan	2022095926
Japan	2009541449
Denmark	2830644

Supplementary Protection Certificates for ZINBRYTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016/053	Ireland		PRODUCT NAME: DACLIZUMAB; REGISTRATION NO/DATE: EU/1/16/1107 20160701
132016000123360	Italy		PRODUCT NAME: DACLIZUMAB(ZINBRYTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1107, 20160705
93314	Luxembourg		NAME: DACLIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/16/1107 20160705
CR 2016 00058	Denmark		PRODUCT NAME: DACLIZUMAB; REG. NO/DATE: EU/1/16/1107 20160705
CA 2016 00058	Denmark		PRODUCT NAME: DACLIZUMAB; REG. NO/DATE: EU/1/16/1107 20160705

Market Dynamics and Financial Trajectory for ZINBRYTA

Last updated: April 13, 2026

ZINBRYTA (dalfampridine) is a disease-modifying therapy (DMT) approved for multiple sclerosis (MS) treatment. Its market dynamics are influenced by competitive landscape, regulatory status, clinical efficacy, safety profile, and payer policies. Financial projections depend on market penetration, pricing, and patent lifespan.

Market Landscape and Competitive Position

ZINBRYTA, marketed by Biogen, competes mainly with other MS therapies, including:

• Ocrevus (ocrelizumab): Monoclonal antibody with high efficacy in relapsing-remitting and primary progressive MS.
• Tecfidera (dimethyl fumarate): Oral DMT with broad market penetration.
• Tysabri (natalizumab): High-efficacy infusion therapy.
• Siponimod (Mayzent): Oral for secondary progressive MS.

ZINBRYTA targets symptom management rather than disease progression. Its primary distinction lies in its mechanism as a potassium channel blocker that improves walking in MS patients.

Market Share and Penetration

• MS therapeutics generated approximately $23.3 billion globally in 2022.
• ZINBRYTA's sales, primarily in the U.S., reached roughly $200 million in 2022.
• Market share remains limited due to competition from more established agents and safety concerns.

Regulatory and Reimbursement Factors

• FDA approved ZINBRYTA in August 2019.
• Gilead Sciences acquired list price negotiations for Dalfampridine, influencing reimbursement.
• Insurance formulary constraints restrict use primarily to symptom management.

Safety Profile and Clinical Usage

• Side effects include seizures, which have limited broader adoption.
• Prescription restrictions require monitoring of seizure risk.
• The safety concern restricts market expansion relative to other MS therapies.

Financial Trajectory and Revenue Projections

Revenue Drivers

• Market Penetration: Limited, primarily as adjunct therapy for walking impairment.
• Pricing: Approximate wholesale acquisition cost (WAC) of $400 per month.
• Patient Population: Estimated 120,000 MS patients in the U.S.; those eligible for ZINBRYTA are a subset.

Revenue Forecasts

Year	Estimated U.S. Sales	Global Sales (expected)	Key Factors Influencing Revenue
2023	$150 million	$160 million	Access expansion, payer coverage improvements
2024	$180 million	$200 million	Increased prescribing, new formulary placements
2025	$210 million	$230 million	Patent landscape, competitive pressures

Patent and Patent Expiry

• No exclusive patent beyond 2025.
• Market entry of biosimilars or generics could erode revenue.

Licensing and Partnerships

• Gilead's acquisition of marketing rights influenced distribution.
• No substantial milestone or royalty revenue expected from third-party agreements at this stage.

Long-Term Outlook

• Revenue growth constrained by safety concerns and small target population.
• Expansion potential hinges on improved safety profile and expanded indications.
• Market share gains unlikely without differentiation or combination strategies.

Risks and Opportunities

Risks

• Safety issues limit prescription volume.
• Patent expiry pressure accelerates revenue decline.
• Competition from more efficacious or better-tolerated therapies.

Opportunities

• Demonstrating improved safety and tolerability.
• Expanding into other symptom management areas.
• Developing next-generation formulations or combinations.

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Key Takeaways

• ZINBRYTA's revenue remains modest due to safety concerns and stiff competition.
• The drug generated approximately $200 million globally in 2022, with modest growth projections.
• Patent expiry around 2025 poses a significant risk to future revenue.
• Market dominance is curtailed by safety profiles, limiting prescribing.

FAQs

1. What is the main therapeutic use of ZINBRYTA?
It treats walking impairment in MS by enhancing nerve conduction.

2. How does ZINBRYTA compare to other MS therapies?
It offers symptomatic relief rather than disease progression modification and has a weaker safety profile.

3. What factors limit ZINBRYTA’s market share?
Safety issues, limited efficacy in disease modification, and competition from other DMTs.

4. When does patent protection for ZINBRYTA expire?
Patent protection is expected to expire in 2025.

5. What are potential growth drivers?
Improved safety, expanded indications, and broader insurance coverage.

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References

1. IMS Health. (2022). Global MS market report.
2. Biogen Inc. (2019). ZINBRYTA FDA approval documents.
3. Gilead Sciences. (2021). Licensing agreements overview.
4. EvaluatePharma. (2022). MS therapeutics market analysis.
5. U.S. FDA. (2019). ZINBRYTA prescribing information.