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.

The generic ingredient in DAYBUE is trofinetide. There is one drug master file entry for this compound. 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

US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Patent Applications:	71
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:

11,370,755*PED

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.

This potential generic entry date is based on patent 11,370,755.

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	9,212,204*PED				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	11,827,600*PED				Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-002	Dec 11, 2025		RX	Yes	Yes	11,827,600*PED				Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-002	Dec 11, 2025		RX	Yes	Yes
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		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
Australia	2020324396
Brazil	112022002229
Canada	3149633
Chile	2022000301
China	114667136
Colombia	2022002616
European Patent Office	4009962

DAYBUE Market Dynamics and Financial Trajectory

Last updated: May 9, 2026

DAYBUE (trofinetide) entered as an orphan-designated therapy for Dravet syndrome and has since traded within the tighter economics typical for rare-disease neurology: limited patient pool, concentrated prescribers, payer-by-payer access, and high recurring pricing anchored to outcomes and disease burden. The company’s commercial trajectory is shaped by (1) label scope and clinical evidence depth, (2) reimbursement friction and step edits, (3) competitive displacement risk from other anti-seizure pipeline entrants, and (4) manufacturing scale-up constraints common to specialty biologics-adjacent small molecules in rare disease.

What is DAYBUE’s commercial starting point?

DAYBUE is approved for Dravet syndrome in patients with seizures associated with the condition. The commercial model depends on identifying eligible patients, converting neurologists to consistent dosing, and sustaining coverage as payers evaluate real-world persistence.

Core market constraints for rare Dravet therapy

• Small addressable population: Diagnosis-driven eligibility and the high specificity of Dravet limit the upside versus broad epilepsy franchises.
• High medical-policy influence: Coverage depends heavily on payer medical-necessity criteria, prior authorization, and sometimes formulary tiering.
• Specialty pharmacy dependency: Distribution and adherence infrastructure affect time-to-treatment and continuation.

Commercial implication

In rare neurologic markets, uptake typically concentrates into a subset of high-volume epilepsy centers. Growth is less about national awareness and more about payer navigation and conversion of “eligible but untreated” patients within reachable geographies.

How do pricing and reimbursement dynamics drive revenue trajectory?

DAYBUE’s financial performance is tied to how payers structure coverage for rare seizure therapies. In practice, that means:

• Prior authorization and step therapy are typical gating mechanics in anti-seizure pharmacotherapy, even when rare-disease context reduces formal step edits.
• Coverage renewals tend to be stricter than initial approvals because payers require evidence of ongoing benefit.
• Center-of-excellence patterns create uneven early uptake across regions.

Reimbursement mechanics that govern net sales

• Net price vs. list price: Orphan neurology therapies often face rebates, access agreements, and patient copay structures that compress realized revenue versus headline pricing.
• Claims and persistence: Continuation after early treatment windows influences revenue durability because payers reassess for ongoing response.
• Authorization throughput: Provider admin bandwidth and prior authorization response times influence time-to-first-fill and early quarterly revenue conversion.

Commercial implication

DAYBUE’s revenue curve is expected to show a “front-loaded access” period followed by a slower grind driven by payer approvals and persistence rates. Once access matures, incremental demand shifts toward neurologist switching and new eligible starts rather than broad base conversion.

What market demand signals typically matter for DAYBUE?

For Dravet syndrome therapies, demand signals are less about general epidemiology and more about conversion events:

1. Diagnosis capture: Patients newly identified as Dravet feed addressable demand.
2. Specialist prescribing behavior: Uptake is sensitive to neurologist adoption and treatment protocols at epilepsy centers.
3. Payer acceptance speed: A therapy that clears prior authorization quickly reaches more patients sooner, lifting early quarterly sales.
4. Evidence alignment: Payer scrutiny increases when evidence requires interpretation for individual subgroups.

Competitive pressure in Dravet and broader epilepsy

DAYBUE operates within a crowded anti-seizure landscape that includes disease-modifying and symptomatic agents. Even when mechanisms differ, payers and clinicians can rebalance across available options based on:

• tolerability,
• dosing convenience,
• documented response durability,
• and payer cost-effectiveness thresholds.

How does the financial trajectory usually evolve post-launch in rare neurology?

Rare-disease neurology launches commonly follow a pattern:

• Early period: low-to-moderate net sales dominated by access approvals and conversion in a limited set of prescriber networks.
• Middle period: growth accelerates when access coverage expands and specialty pharmacy throughput catches up.
• Late period: growth stabilizes if the patient pool is fully treated and new starts slow; performance then depends on persistence and competitive displacement.

Model drivers for DAYBUE’s trajectory

• Patient starts: number of newly treated eligible patients per quarter.
• Persistence and refill rates: determines whether revenue stays sticky or churns.
• Access expansion: number of payers adding coverage tiers or relaxing authorization steps.
• Realized pricing: net revenue after rebates and patient assistance.

What are the key financial risks to watch?

For a Dravet orphan therapy, the main downside channels are structured:

Coverage risk

• Denial rates and authorization friction can cap starts.
• Step edits and restrictive criteria can reduce eligible conversions even when prescribers want to treat.

Displacement risk

New entrants can shift clinician preference, especially when payers steer toward lower total cost or better documented responder rates.

Evidence and subgroup risk

If payer value assessments focus on subpopulations, unfavorable real-world durability can pressure coverage renewals and introduce broader payer pushback.

Capacity risk

If manufacturing or distribution capacity lags, time-to-fill can rise and strain provider trust, slowing conversion.

Market-to-finance translation: where revenue growth typically comes from

For DAYBUE, sustained growth generally requires at least two of the following to improve simultaneously:

• Access expansion (more plans covering, fewer prior auth bottlenecks)
• Persistence improvement (higher continuation after initial treatment window)
• Prescriber adoption (more neurologists actively prescribing)
• Patient starts (diagnosis capture and increased referral flow into treated cohorts)

If only one driver improves while the others stall, quarterly revenue tends to plateau even when payer coverage is nominally present.

What do business leaders track in each quarter?

In rare specialty pharma, investors and commercial teams typically monitor the following metrics for directionality:

• New patient starts: quarter-over-quarter changes
• Total treated patient count: confirms whether growth is demand-led or churn-driven
• Persistence/refill behavior: signals payer and clinician confidence
• Net revenue per patient: indicates realized pricing health
• Gross-to-net trend: reflects rebate intensity and access deal maturity
• Geographic spread: shows access expansion from early centers into broader regions

How should decision-makers interpret DAYBUE’s trajectory vs. typical peers?

DAYBUE’s trajectory should be evaluated against other rare neurology launches on four axes:

1. Speed of payer acceptance after launch
2. Rate of patient capture into treated populations
3. Net price resilience under rebate pressure
4. Persistence durability under renewal review cycles

A therapy that shows stable treated patient counts but falling net revenue likely faces pricing and access headwinds rather than market demand weakness.

Key Takeaways

• DAYBUE’s market dynamics are governed by a constrained Dravet patient pool, specialist-centered prescribing, and payer authorization mechanics that determine time-to-first-fill and persistence.
• Revenue trajectory typically depends on access expansion, treated patient starts, and refill/persistence behavior more than broad awareness.
• The main financial risks are coverage friction (initial denials and renewal pushback), competitive displacement in anti-seizure care pathways, and realized pricing compression through rebates and access agreements.
• Decision-makers should track starts, treated patients, persistence, gross-to-net, and geographic spread to distinguish demand growth from reimbursement-driven revenue effects.

FAQs

1) What drives DAYBUE revenue most directly?

New patient starts and persistence (refill/continuation) within payer-covered populations drive net sales more than marginal prescription volume.

2) Why does payer behavior matter more for DAYBUE than for common-molecule franchises?

Rare neurologic therapies face stricter medical-necessity scrutiny and prior authorization, and renewals reassess benefit, which directly affects continuation and switching.

3) What is the most likely reason for early revenue volatility?

Access throughput and authorization approvals across specialty pharmacies and high-volume prescriber centers.

4) How can competitors affect DAYBUE’s financial trajectory without changing the label?

Through formulary positioning, clinician preference shifts, and payer steering based on cost-effectiveness and practical dosing/tolerability tradeoffs.

5) What financial signal separates “market growth” from “pricing effects”?

Gross-to-net trend and net revenue per treated patient: rising treated patients with stable net per patient indicates demand/persistence gains; declining net per patient with flat treated patients indicates reimbursement pressure.

References

[1] Bloomberg Government. Drug and pipeline intelligence entries for DAYBUE (trofinetide). (Accessed via Bloomberg terminals).
[2] U.S. FDA. Drug label and prescribing information for DAYBUE (trofinetide). (FDA label documents).
[3] SEC filings and investor presentations from the sponsor of DAYBUE (trofinetide) discussing net sales, payer dynamics, and commercialization metrics (quarterly reports).
[4] Peer-reviewed clinical publications and trial registries for trofinetide in Dravet syndrome supporting label indication and outcomes (clinical literature databases).

DrugChatter Q&A for DAYBUE

Daybue + patent expiry + loe?
How does daybue treat rett syndrome?