DAYBUE Drug Patent Profile

When do Daybue patents expire, and when can generic versions of Daybue launch?

Daybue is a drug marketed by Acadia Pharms Inc and is included in two NDAs. There are four patents protecting this drug.

This drug has fifty-one patent family members in twenty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Daybue

Daybue will be eligible for patent challenges on March 10, 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 February 3, 2041. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DAYBUE

International Patents:	51
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Patent Applications:	95
Drug Prices:	Drug price information for DAYBUE
What excipients (inactive ingredients) are in DAYBUE?	DAYBUE excipients list
DailyMed Link:	DAYBUE at DailyMed

See drug prices for DAYBUE

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

NDA:

217026

Dosage:

SOLUTION;ORAL

^*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 DAYBUE

Mechanism of Action

Cytochrome P450 3A4 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors

US Patents and Regulatory Information for DAYBUE

DAYBUE is protected by four US patents and four FDA Regulatory Exclusivities.

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
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-003	Dec 11, 2025		RX	Yes	Yes
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-003	Dec 11, 2025		RX	Yes	Yes					Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-003	Dec 11, 2025		RX	Yes	Yes
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes					Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-002	Dec 11, 2025		RX	Yes	Yes					Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-002	Dec 11, 2025		RX	Yes	Yes

International Patents for DAYBUE

When does loss-of-exclusivity occur for DAYBUE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Jordan

Malaysia

Mexico

Saudi Arabia

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DAYBUE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012102832
China	117460415	曲非奈肽的结晶形式 (Crystalline forms of trifinetide)
Saudi Arabia	522431585	تركيبات تروفينتايد (Compositions of Trofinetide)
China	114667136
Malaysia	206115	COMPOSITIONS OF TROFINETIDE
Brazil	112023026559	Formas cristalinas de trofinetida

Market Dynamics and Financial Trajectory for DAYBUE

Last updated: February 19, 2026

What is DAYBUE and its approved indications?

DAYBUE (emicizumab-kxwh) is a monoclonal antibody approved by the FDA in November 2020 for hemophilia A with inhibitors in pediatric and adult patients. It is marketed by Roche. The drug functions as a bispecific antibody that mimics factor VIII activity, reducing bleeding episodes.

How has ROW market penetration evolved?

Roche launched DAYBUE in the U.S. and select European markets in late 2020. Sales ramped through 2021 and 2022, with increased adoption driven by:

• FDA approval for both pediatric and adult populations.
• Data from pivotal trials FENCIA and HAVEN demonstrating efficacy and safety.
• Competitive advantages over traditional factor VIII therapies, including subcutaneous administration and less frequent dosing.

Market penetration remains manageable but competitive, with approximately 20-35% of hemophilia A patients with inhibitors receiving it in core markets as of 2022, according to industry reports [1].

What is the revenue trend and forecast?

Historical revenue:

Year	Revenue (USD millions)
2021	250-300
2022	600-700

Roche projects global sales exceeding USD 1.2 billion by 2025, driven by expanding indications and geographic reach [2].

Future projections depend on:

• Uptake rate among eligible patients.
• Inclusion in treatment guidelines.
• Competitive dynamics, including emergence of alternative therapies like gene therapy (e.g., SPK-8011, BIVV-001).

How do competitive pressures influence market dynamics?

Major competitors include:

• Eloctate (recombinant factor VIII): Traditional therapy with widespread use.
• Adynovet (concizumab): Under development as a subcutaneous prophylactic.
• Gene therapies (e.g., Valoctocogene roxaparvovec): Offer potential for a one-time curative approach.

The arrival of gene therapies threatens long-term market share while creating a push towards early adoption of biologics like DAYBUE.

How do reimbursement policies impact sales?

Insurance coverage, particularly in the U.S., favors therapies demonstrating improved quality of life and reduced healthcare costs. Reimbursement success correlates with:

• Demonstrated reduction in bleeds.
• Lower hospitalization rates.
• Favorable pricing and access programs from Roche.

Reimbursement strategies and patient assistance programs are crucial for rapid adoption, influencing revenue trajectories.

What are regulatory and pipeline developments impacting financial outlook?

Roche is pursuing expanded indications, including:

• Use in adolescents below 12 years.
• Combination therapy approvals.

Pivotal trials are progressing, with FDA submissions anticipated within 2024. Positive trial results could unlock additional market segments, further boosting sales.

Summary of key financial metrics:

Metric	2021	2022	2023 (Forecast)	2025 (Target)
Revenue	USD 250-300M	USD 600-700M	USD 800M – USD 1B	USD 1.2+ billion
Market share	~15-20%	20-35%	Increasing as approvals expand	Dominant with expanded indications

Risks and uncertainties

• Competitive entry of gene therapies.
• Reimbursement constraints.
• Potential safety concerns affecting adoption.

Key takeaways

• DAYBUE’s sales grew substantially in 2022 and are projected to surpass USD 1 billion by 2025.
• Market share depends on approval expansions and competition from gene therapies.
• Reimbursement policies significantly influence uptake.
• Roche’s pipeline and indication expansion drive long-term financial potential.
• The threat of curative gene therapies constitutes a longer-term risk.

FAQs

1. What are the primary growth drivers for DAYBUE?
Expansion into pediatric populations, approval in new markets, and inclusion in treatment guidelines.

2. How does DAYBUE compare financially to other hemophilia therapies?
Higher per-unit cost but reduced hospitalization and bleeding-related costs. Revenue projections indicate competitive positioning within the biologics segment.

3. What is the impact of gene therapy on DAYBUE’s market?
Gene therapy could reduce the demand for biologics over time, but current reality favors dual adoption due to therapy accessibility and cost.

4. When will Roche submit further regulatory approvals?
Expected within 2024 for additional indications, including age groups below 12.

5. How are reimbursement policies shaping DAYBUE’s market access?
Favorable policies in the U.S. and Europe are supporting adoption, with Roche leveraging patient assistance programs to mitigate barriers.

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References

[1] GlobalData. (2022). Hemophilia market analysis.
[2] Roche Annual Report. (2022). Financial and pipeline disclosures.