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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 forty-eight patent family members in twenty-three 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:	48
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Patent Applications:	23
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.

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
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			Y	Y
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes			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
China	117460415	曲非奈肽的结晶形式 (Crystalline forms of trifinetide)
South Korea	20220059479	트로피네타이드의 조성물
Israel	310045	צורות גבישיות של טרופינטיד (Crystalline forms of trofinetide)
World Intellectual Property Organization (WIPO)	2012102832
Israel	290324	תכשירים המכילים טרופינטיד (Compositions of trofinetide)
Australia	2020324396	Compositions of trofinetide

Market Dynamics and Financial Trajectory for DAYBUE (Trofinetide)

Introduction to DAYBUE

DAYBUE, also known as trofinetide, is a drug developed by Neuren Pharmaceuticals and commercialized by Acadia Pharmaceuticals. It is approved by the FDA for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. Here, we delve into the market dynamics and financial trajectory of DAYBUE.

Approval and Market Entry

DAYBUE was launched in April 2023, marking a significant milestone in the treatment of Rett syndrome, a rare genetic disorder[5].

Initial Market Reception

The initial market reception of DAYBUE has been positive. In the fourth quarter of 2023, DAYBUE generated net product sales of $87.1 million, and for the full year 2023, it achieved $177.2 million in sales. This strong start is attributed to the lack of existing disease-modifying drugs for Rett syndrome and the broad label that includes a wide age range of patients[5].

Financial Performance

Quarterly and Annual Sales

In the first quarter of 2024, DAYBUE net sales reached $75.9 million, which was within the guided range of $76 to $82 million. This contributed to Acadia Pharmaceuticals' total net product sales of $205.8 million for the quarter, representing a 74% year-over-year revenue growth[1][3].

For the second quarter of 2024, total revenues from DAYBUE and NUPLAZID were $242.0 million, with DAYBUE contributing significantly to this growth. However, the full-year guidance for DAYBUE net sales was adjusted to a range of $340 to $370 million, down from the previous range of $370 to $420 million[2].

Revenue Growth and Projections

The revenue growth of DAYBUE is substantial and reflects strong market adoption. The drug's performance has driven Acadia Pharmaceuticals' overall revenue growth, with total revenues for the first half of 2024 reaching $447.8 million, up from $283.7 million in the same period of 2023[2].

Global Expansion

Acadia Pharmaceuticals is focusing on expanding DAYBUE globally, including markets in Europe, Japan, and Canada. This expansion is expected to further boost sales and market penetration[1][3].

Research and Development

Ongoing Trials and Pipeline

In addition to its commercial success, DAYBUE is part of Acadia Pharmaceuticals' robust pipeline. The company is conducting ongoing Phase 3 trials for other indications, such as Prader-Willi syndrome and Alzheimer's disease psychosis. These trials are part of a seamless Phase 2/3 program for ACP-204 and a Phase 3 study for ACP-101[1][3].

R&D Expenses

Research and development expenses for Acadia Pharmaceuticals have been significant but are expected to be within the guided range of $305 to $315 million for 2024. This investment is crucial for advancing the pipeline and supporting the commercial success of DAYBUE and other products[2][5].

Selling, General, and Administrative Expenses

Commercial Costs

The launch of DAYBUE has led to increased commercial costs, which are reflected in the higher selling, general, and administrative expenses. For the full year 2023, these expenses were $406.6 million, up from $369.1 million in 2022. The guidance for 2024 places these expenses between $465 to $480 million[2][5].

Cash Flow and Financial Strength

Cash Balance and Operational Cash Flow

As of March 31, 2024, Acadia Pharmaceuticals had a cash balance of $470.5 million. The company has substantial and growing cash flow from operations, which supports its business plan and strategic initiatives, including the global expansion of DAYBUE[1].

Analyst Perspectives and Market Impact

Positive Market Reception

Analysts have been positive about the market adoption of DAYBUE. The initial sales figures have exceeded expectations, leading to increased price targets by several analysts. For example, HC Wainwright increased its price target from $28 to $33, citing the promising initial net sales data for DAYBUE[4].

Strategic Advancements

The successful launch of DAYBUE has reinforced Acadia Pharmaceuticals' strategic moves, including the acquisition of global rights to trofinetide and the addition of other pipeline assets. This strategic expansion is seen as a solid path to profitability[4].

Key Takeaways

• Strong Initial Sales: DAYBUE has seen robust sales since its launch in April 2023, contributing significantly to Acadia Pharmaceuticals' revenue growth.
• Global Expansion: Efforts are underway to expand DAYBUE into international markets, including Europe, Japan, and Canada.
• Research and Development: Ongoing trials for additional indications and a strong pipeline support the long-term potential of DAYBUE.
• Financial Strength: Acadia Pharmaceuticals maintains a strong cash balance and positive cash flow from operations.
• Analyst Confidence: Positive analyst perspectives and increased price targets reflect confidence in DAYBUE's market performance.

FAQs

What is DAYBUE used for?

DAYBUE (trofinetide) is used for the treatment of Rett syndrome in adults and pediatric patients two years of age and older.

How has DAYBUE performed financially since its launch?

DAYBUE has generated significant revenue since its launch, with Q1 2024 sales reaching $75.9 million and full-year 2023 sales of $177.2 million.

What are the future sales projections for DAYBUE?

The full-year 2024 guidance for DAYBUE net sales has been adjusted to a range of $340 to $370 million.

Is DAYBUE available globally?

Currently, DAYBUE is only approved in the United States, but Acadia Pharmaceuticals is working on international expansion.

What other pipeline assets does Acadia Pharmaceuticals have?

Acadia Pharmaceuticals is conducting trials for ACP-101 in Prader-Willi syndrome and ACP-204 in Alzheimer's disease psychosis, among other pipeline assets.

Sources

1. Neuren Pharmaceuticals: "DAYBUE™ Q1 2024 net sales US$75.9 million, full-year guidance US$370-420 million" - ASX Announcement, May 9, 2024.
2. Acadia Pharmaceuticals: "Acadia Pharmaceuticals Reports Second Quarter 2024 Financial Results" - News Release, June 2024.
3. StockTitan: "Acadia Pharmaceuticals Reports First Quarter 2024 Financial Results and Operating Overview" - News, May 8, 2024.
4. Business Insider: "Reassuring Market Adoption of Daybue Fuels Acadia's Strategic Advancements, Analysts Boost Price Targets" - Article, July 14, 2023.
5. Acadia Pharmaceuticals: "Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operating Overview" - News Release, 2023.