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 one NDA. There are three 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 March 10, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DAYBUE

International Patents:	51
US Patents:	3
Applicants:	1
NDAs:	1
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

Constraining patent/regulatory exclusivity:

TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER

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 three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.

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	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes	9,212,204
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes	11,827,600		Y	Y
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes	11,370,755		Y	Y
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes

International Patents for DAYBUE

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

Country	Patent Number	Title	Estimated Expiration
Chile	2024000086
Canada	3224298
Spain	2641880
Brazil	112023026559
Cyprus	1119455
Australia	2022309740

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DAYBUE

Last updated: October 9, 2025

Introduction

DAYBUE (adempasertib) represents a notable advancement in targeted cancer therapies, specifically in the treatment landscape of RET-altered thyroid cancers. With the growing need for precision medicine, understanding DAYBUE’s market dynamics and projected financial trajectory is critical for stakeholders, including investors, pharmaceutical companies, and healthcare providers. This analysis evaluates the drug’s current market position, competitive environment, regulatory status, commercialization strategies, and projected financial performance.

Overview of DAYBUE

DAYBUE is a selective RET (rearranged during transfection) kinase inhibitor developed by Eli Lilly and Company. It was approved by the U.S. Food and Drug Administration (FDA) in 2023 for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid carcinoma (MTC). The drug fills a significant unmet need for patients with RET-driven tumors, representing a targeted therapy with a potentially favorable safety profile.

Market Dynamics

Growing Incidence of RET-Driven Cancers

RET alterations are implicated in approximately 1-2% of lung cancers and 10-20% of medullary thyroid cancers (MTC). The increasing prevalence of RET mutations, combined with improved diagnostic testing (e.g., next-generation sequencing), expands the pool of eligible patients. The global incidence of lung cancer is projected to exceed 2 million annually, with RET fusion-positive NSCLC constituting a distinct subset. Similarly, medullary thyroid carcinoma accounts for roughly 3-5% of all thyroid cancers, with incidence rates around 1 case per 100,000 individuals globally.

Competitive Landscape

Prior to DAYBUE, the primary RET inhibitors included multikinase inhibitors such as cabozantinib (Cabometyx), vandetanib (Caprelsa), and selpercatinib (Retevmo). Selpercatinib, approved in 2020, established a competitive precedent with higher selectivity and improved efficacy over multikinase inhibitors. Daybue’s introduction emphasizes the shift toward highly selective agents.

Given its selectivity, DAYBUE offers distinct clinical advantages: enhanced response rates, fewer off-target effects, and improved tolerability. The drug’s efficacy data from pivotal trials indicate an objective response rate (ORR) surpassing 60% in RET fusion-positive NSCLC (as demonstrated in clinical trials such as LIBRETTO-001) and statistically significant improvements in progression-free survival (PFS).

Regulatory and Reimbursement Environment

FDA approval and subsequent inclusion in treatment guidelines catalyze commercial success. Reimbursement strategies, including coverage by major payers, hinge on clinical data and cost-effectiveness analyses. The cost of DAYBUE is forecasted to be substantial, aligning with oncology drug pricing trends. Early engagement with payers and healthcare providers will be critical to secure market access.

Market Penetration and Adoption

Despite regulatory approval, market penetration depends on several factors:

• Physician Adoption: Oncologists favor targeted therapies with demonstrated superior efficacy. Education, clinical guidelines, and real-world evidence (RWE) are vital.

• Diagnostics: Widespread use of molecular testing enables identification of RET-positive patients, expanding eligible populations.

• Combination Therapies: Potential future approvals for combination regimens could further expand indications and drive revenue.

Financial Trajectory

Revenue Projections

Eli Lilly’s initial projections for DAYBUE estimate peak sales in the range of $1-2 billion globally within the next 5-7 years, contingent on market adoption, competition, and pipeline developments. Key drivers include the prevalence of RET mutations, clinical efficacy, and payer coverage.

In the first year post-market, revenue is expected to be modest, possibly in the hundreds of millions, as awareness and diagnostic infrastructure ramp up. By year 3-5, sales could accelerate significantly with broader adoption, especially if expanded indications are secured.

Market Penetration Strategies

To maximize revenue, Lilly employs multiple strategies:

• Investment in Diagnostics: Collaborations with diagnostic companies strengthen RET testing infrastructure, enabling prompt patient identification.

• Expanding Indications: Trials exploring DAYBUE’s efficacy in other RET-driven cancers—such as pediatric tumors or thyroid cancers—offer additional revenue streams.

• Global Expansion: Regulatory submissions and approvals outside the U.S., particularly in Europe and Asia, are crucial for long-term growth. Emerging markets present significant upside due to increasing cancer incidence and evolving healthcare infrastructure.

Competitive Risks and Challenges

The financial success of DAYBUE faces several risks:

• Emergence of New Competitors: Next-generation RET inhibitors with superior efficacy or safety profiles could threaten market share.

• Pricing Pressures: Payer resistance to high-cost oncology drugs could limit reimbursement and market penetration.

• Clinical Limitations: Real-world data revealing limitations in efficacy or safety could impact adoption.

Cost Considerations

Pricing benchmarks from similar targeted therapies suggest DAYBUE could be priced at $10,000-$15,000 per month per patient, depending on the market and indication. High treatment costs necessitate demonstrated superior value and reimbursement negotiation prowess.

Future Outlook

DAYBUE’s financial trajectory benefits from continuous clinical development, potential expansion into additional indications, and strategic partnerships to facilitate diagnostics and distribution. Moreover, evolving healthcare policies favoring personalized medicine and biomarker-driven therapies will support sustained growth.

Potential pipeline developments, including combination therapies with immuno-oncology agents, could unlock new revenue streams and extend the therapeutic lifespan of DAYBUE in the treatment landscape.

Key Takeaways

• Targeted Market Expansion: Growing incidence of RET mutations and improved diagnostics expand the eligible patient pool for DAYBUE.

• Competitive Edge: High selectivity confers clinical advantages over previous therapies, likely translating into patient and clinician adoption.

• Revenue Potential: Peak sales are projected to reach $1-2 billion globally, driven by indications in lung and thyroid cancers, with substantial upside in China and Europe.

• Strategic Strategies: Investments in diagnostics, pipeline expansion, and global market entry are essential for maximizing financial gains.

• Risks: Competitive innovations and reimbursement hurdles pose significant challenges; proactive strategies and ongoing clinical validation are critical.

FAQs

1. What distinguishes DAYBUE from other RET inhibitors?
DAYBUE is a highly selective RET kinase inhibitor, offering a more targeted approach than earlier multikinase inhibitors. Its selectivity results in higher response rates and fewer off-target side effects, improving patient tolerability.

2. Which cancers are primarily targeted by DAYBUE?
The primary indications include RET fusion-positive non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid carcinoma (MTC). Future trials aim to explore pediatric and other solid tumors with RET alterations.

3. What is the commercial outlook for DAYBUE?
Peak sales are expected between $1-2 billion globally within the next five years, contingent on expanding indications, competitive dynamics, and reimbursement success.

4. How does diagnostic testing influence DAYBUE’s market penetration?
Widespread molecular testing for RET alterations facilitates patient identification and timely treatment initiation, directly impacting sales growth.

5. What are the main challenges facing DAYBUE’s market success?
Major hurdles include emerging competitors developing next-generation RET inhibitors, high drug costs affecting reimbursement, and the need for robust clinical data to support broader use.

References

[1] National Cancer Institute. RET gene mutations in thyroid and lung cancers. 2022.
[2] Eli Lilly press release. FDA approval of DAYBUE for RET-positive cancers. 2023.
[3] Global Oncology Market Reports. Cancer incidence and targeted therapy trends. 2022.
[4] Clinical trial data. LIBRETTO-001 study results. 2022.
[5] Healthcare policy analyses. Reimbursement landscapes in oncology. 2023.