DAYBUE STIX Drug Patent Profile

Which patents cover Daybue Stix, and when can generic versions of Daybue Stix launch?

Daybue Stix is a drug marketed by Acadia Pharms Inc and is included in one NDA. There are four patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Daybue Stix

Daybue Stix 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 STIX

International Patents:	52
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	DAYBUE STIX at DailyMed

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

Constraining patent/regulatory exclusivity:

11,370,755*PED

NDA:

219884

Dosage:

FOR 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 STIX

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 STIX

DAYBUE STIX 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	219884-001	Dec 11, 2025		RX	Yes	Yes	12,492,167*PED				Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-003	Dec 11, 2025		RX	Yes	Yes	11,827,600*PED				Y
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	219884-001	Dec 11, 2025		RX	Yes	Yes
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-001	Dec 11, 2025		RX	Yes	Yes	9,212,204*PED				Y
Acadia Pharms Inc	DAYBUE STIX	trofinetide	FOR SOLUTION;ORAL	219884-002	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	9,212,204*PED				Y

International Patents for DAYBUE STIX

When does loss-of-exclusivity occur for DAYBUE STIX?

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 STIX 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 (stiripentol) STIX: market dynamics and financial trajectory

Daybue STIX is a niche, highly controlled pediatric CNS product with growth constrained by prescriber base, narrow labeled population, and payer access friction. Near-term trajectory is dominated by (1) uptake by pediatric neurology centers treating Dravet syndrome, (2) coverage decisions tied to formulary placement and prior authorization, and (3) substitution pressure from broader rescue regimens for uncontrolled seizures rather than direct “generic” competition. Financial performance is typically characterized by lumpy quarterly demand due to specialty distribution and patient starts, with revenue scaling primarily through patient share gains rather than dose intensification.

What is Daybue STIX (stiripentol) and where does it fit in Dravet syndrome treatment economics?

Daybue STIX is stiripentol in a pediatric-friendly stick formulation intended to support administration for children with Dravet syndrome who are on clobazam-based regimens and other antiseizure therapy. Market dynamics track to two drivers: the Dravet syndrome incident pool (new diagnoses and therapy transitions) and retention (staying on regimen as seizure control stabilizes).

Economic fit within Dravet workflows

Last updated: June 1, 2026

• Initiation typically occurs after inadequate control on standard antiseizure therapy, with clobazam commonly in the background regimen.
• Adjustments are made by pediatric neurology teams using seizure diaries, rescue medication use, and safety monitoring to justify continuing therapy.
• Stick formulation is a practical adherence lever in pediatric dispensing, reducing caregiver burden and administration friction.

Who buys and who influences?

• Buyers are mostly PBM-administered commercial plans and state Medicaid programs for pediatric patients.
• Influencers include pediatric neurologists and epilepsy specialty pharmacists at integrated delivery networks.
• Access is mediated via prior authorization, step therapy logic, and medical-necessity documentation around seizure burden and treatment history.

How fast can Daybue STIX grow given the Dravet syndrome patient pool and specialty channel constraints?

Growth rate is constrained by a limited addressable population and specialty pharmacy operating parameters.

Patient pool math that drives revenue

• Dravet syndrome prevalence is low relative to broader epilepsy categories, making total revenue sensitive to incremental market share.
• Revenue increases come from additional patient starts and continuation, not from broad penetration into general epilepsy populations.
• Retention depends on tolerability and caregiver acceptance. Pediatric CNS drugs often face discontinuation risks due to sedation or gastrointestinal effects and the monitoring burden.

Specialty channel reality

• Specialty distribution reduces “immediacy” of sales versus retail models.
• Quarterly revenue can swing with patient start counts, insurance authorization cycles, and inventory positioning with specialty pharmacies.
• Reimbursement outcomes at the plan level drive most of the timing variability.

What market forces shape pricing, reimbursement, and access for Daybue STIX?

Payer dynamics for orphan-like pediatric CNS drugs are usually characterized by: (1) coverage controls, (2) copay management infrastructure, and (3) utilization management.

Key reimbursement levers

• Prior authorization requirements and diagnosis confirmation (Dravet syndrome documentation).
• Step therapy or evidence standards requiring prior clobazam co-therapy history or inadequate response to earlier regimens.
• Specialty pharmacy contracting terms that govern net pricing.

Net price compression risk

• The highest risk to financial trajectory is net price compression via PBM negotiations or tighter PA scrutiny that reduces realized units at higher discounts.
• Copay assistance can sustain patient demand, but PBM restrictions can mute net sales growth by limiting eligible members or increasing administrative barriers.

Competitive substitutes Even when there is no direct “generic” stiripentol substitute, switching can occur to other adjunctive therapies or rescue optimization strategies. That indirect substitution is the main headwind for incremental patient share.

How does Daybue STIX revenue typically break down across cohorts (new starts vs. continuing patients)?

The revenue curve for specialty pediatric CNS drugs is usually dominated by continuation. New patient starts provide upside, but retention sustains the base.

Commercial cohort behavior

• New starts: demand is episodic, tied to diagnosis events, therapy transitions, and insurance authorization processing.
• Continuing patients: forms the steady portion of revenue as long as safety and seizure outcomes remain acceptable.
• Dose changes: stick formulation helps adherence, but dosing frequency and caregiver routines can still drive discontinuation risk if tolerability is poor.

Implication for financial trajectory

• Any improvement in payer access that reduces PA friction tends to convert into faster start volumes.
• Any increase in authorization denials or documentation burdens slows unit growth even if prescribers are willing.

What are the financial trajectory benchmarks for Daybue STIX investors and licensors should track?

Financial trajectory should be monitored through KPIs that map to specialty drug economics.

Revenue KPIs

• New patient start volume (or prescriptions filled) and time to therapy initiation.
• Net sales vs. gross-to-net ratio (rebates, discounts, copay assistance impacts).
• Persistence/continuation rates in pediatric CNS cohorts.

Operating KPIs

• Medical affairs burden for PA approvals and appeal outcomes.
• Specialty pharmacy fill rates and inventory turns at the distribution node.
• Patient support program engagement and denial rates.

When does Daybue STIX lose exclusivity, and how does that affect long-term revenue?

Long-term revenue sensitivity is linked to IP exclusivity in stiripentol, formulation, and method-of-treatment claims, plus any data exclusivity anchored to the specific FDA-licensed product and route.

What usually determines exclusivity cliffs

• Composition-of-matter patents on the active ingredient stiripentol.
• Formulation patents (stick/powder presentation, excipient systems, stability).
• Method-of-use patents (Dravet regimen placement, co-administration logic).
• Exclusivity periods tied to FDA approvals and supplemental approvals.

Commercial impact pathway

• Loss of exclusivity typically first affects the probability of generic or authorized generic entry rather than immediately shifting usage.
• Even after legal exclusivity ends, practical entry depends on manufacturing readiness and regulatory clearance, and payers often maintain utilization controls for a period.

What patents protect Daybue STIX and how strong is the patent estate?

A complete patent-strength assessment requires Orange Book and litigation dockets specific to the marketed Daybue STIX NDA product, including listed patents, expiration dates, and claim scope. No such product-level patent listing details are provided in the request.

What is the Orange Book status of Daybue STIX?

Orange Book status is determined by listed patents and exclusivity codes for the specific NDA/BLA and dosage form. No Orange Book listings, NDA number, or listed patent set are provided in the request.

Is there a Paragraph IV or generic entry risk for Daybue STIX?

Paragraph IV risk is tied to actual ANDA filings referencing the NDA and the FDA’s publicly available notice data. No ANDA, Paragraph IV notice, or litigation notice detail is provided in the request.

What biosimilar risks exist for Daybue STIX?

Daybue STIX is a small-molecule product, so biosimilar pathways do not apply. No biologics are implicated.

How does Daybue STIX compare with competing adjunctive antiseizure therapies for market share?

Market share depends on sequencing and payer preferences among adjunctive options for Dravet syndrome. Without a defined competitor set and pricing/reimbursement data, comparison requires molecule-by-molecule evidence that is not included in the request.

What patent litigation affects Daybue STIX commercialization and settlements?

Patent litigation impacts commercialization through launch delays, injunction risk, and settlement-triggered entry calendars. No litigation docket information for Daybue STIX is provided in the request.

What does the FDA regulatory timeline imply for Daybue STIX sales scaling?

FDA timing affects sales through launch readiness, distribution setup, and label-specific uptake. No FDA milestone dates, approval history, or supplements for Daybue STIX are provided in the request.

Which companies dominate the Daybue STIX ecosystem (manufacturer, distributors, payer channels)?

Ownership and commercialization structure shape distribution velocity. No manufacturer/label holder details or named specialty distributors are provided in the request.

What generic entry risks exist for stiripentol formulations if exclusivity ends?

Generic entry risk is driven by:

• feasibility of matching formulation and dissolution characteristics,
• stability and manufacturing controls,
• likelihood of regulatory challenges around bioequivalence for pediatric dosing.

No product-level formulation patent and manufacturing disclosure details are provided in the request.

Revenue exposure: how sensitive is Daybue STIX to pediatric neurology prescribing shifts?

Sensitivity is high because Dravet syndrome is clinician-driven and small patient counts amplify share changes.

High-sensitivity levers

• Changes in clinical guidelines or payers’ preferred adjunctive therapy lists.
• Introduction of alternative therapies that achieve seizure control with less monitoring or improved tolerability.
• Administrative burden shifts that either expand access or tighten PA criteria.

Stabilizers

• Demonstrated caregiver adherence benefits from stick format.
• Continuation when seizure control is maintained and safety is manageable.

Key Takeaways

• Daybue STIX financial trajectory is driven mainly by pediatric Dravet patient starts and retention, with specialty pharmacy and payer authorization cycles creating quarterly volatility.
• The market is niche and indirect substitution by other adjunctive seizure strategies is the primary competitive pressure, not generic displacement in the near term.
• Long-term revenue depends on IP/exclusivity durability tied to formulation and method-of-use protection, plus actual regulatory and litigation events.
• Investors and licensing stakeholders should track specialty KPIs: new start volume, persistence, gross-to-net, PA approval rates, and any patent/exclusivity milestone disclosures.

FAQs

1. How do prior authorization and step therapy affect Daybue STIX net sales?
2. What specialty pharmacy metrics best predict Daybue STIX quarter-to-quarter revenue?
3. How do formulation-specific advantages of stick dosing change persistence in pediatric seizure therapy?
4. What indicators signal increased generic substitution risk for stiripentol formulations?
5. How should licensors model revenue when exclusivity lapses but launch uptake is delayed?

References (APA)

1. (No sources were provided in the request.)