NAYZILAM Drug Patent Profile

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

Nayzilam is a drug marketed by Ucb Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NAYZILAM is midazolam. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.

DrugPatentWatch^® Generic Entry Outlook for Nayzilam

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (midazolam), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NAYZILAM

US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Patent Applications:	4,544
Drug Prices:	Drug price information for NAYZILAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAYZILAM
What excipients (inactive ingredients) are in NAYZILAM?	NAYZILAM excipients list
DailyMed Link:	NAYZILAM at DailyMed

See drug prices for NAYZILAM

Pharmacology for NAYZILAM

Drug Class

Benzodiazepine

Paragraph IV (Patent) Challenges for NAYZILAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAYZILAM	Nasal Spray	midazolam	5 mg/spray	211321	1	2021-06-01

US Patents and Regulatory Information for NAYZILAM

NAYZILAM is protected by four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes			Y
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes			Y
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes			Y
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes			Y
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for NAYZILAM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Neuraxpharm Pharmaceuticals S.L.	Buccolam	midazolam	EMEA/H/C/002267Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.	Authorised	no	no	no	2011-09-04

Market Dynamics and Financial Trajectory for NAYZILAM

Last updated: February 20, 2026

What is NAYZILAM?

NAYZILAM (midazolam nasal spray) is a prescription medication indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, including status epilepticus, in patients aged 12 years and older. Developed by Sojournix LLC, a subsidiary of Charles River Laboratories, NAYZILAM was approved by the U.S. Food and Drug Administration (FDA) in November 2020[1].

Market Size and Growth Potential

Epilepsy and Seizure Market Overview

The epilepsy market is estimated at approximately $5.7 billion globally in 2022. The United States accounts for roughly 55% of this market, driven by high prevalence and reimbursement access[2].

Market Segments Relevant to NAYZILAM

• Rescue medications: Including nasal sprays, rectal gels, and injectable drugs for seizure episodes.
• Target population: Patients aged 12 and above with known seizure disorders experiencing episodic seizures.

Competition and Market Share

Primary competitors in rescue treatment include:

Product	Delivery Method	Market Launch Year	Estimated U.S. Market Share (2022)	Key Differentiator
Diastat (valium rectal gel)	Rectal gel	1982	60%	Established, older formulation
Valtoco (diazepam nasal spray)	Nasal spray	2019	25%	Nasal route, approved pre-NAYZILAM
NAYZILAM (midazolam nasal spray)	Nasal spray	2020	10%	First FDA-approved nasal midazolam

Growth Drivers

• Increased epilepsy awareness
• Need for non-invasive, rapid-acting rescue options
• Advancements in nasal drug delivery technologies
• Potential off-label uses in status epilepticus management

Challenges

• Competition from established products
• Prescriber and patient familiarity
• Pricing and reimbursement pressures
• Limited adoption due to market inertia

Revenue and Sales Trajectory

Initial Sales Performance

NAYZILAM registered approximately $20 million in U.S. sales in its first full year (2021). Analysts project sales to reach $50 million by 2024, based on prescriber adoption rates and market penetration[3].

Factors Affecting Growth

• Expansion into broader epilepsy treatment settings
• Increased clinician and caregiver education
• Payer coverage and formulary inclusion
• Potential for international expansion, notably in Europe and Asia

Revenue Expansion Strategies

• Direct-to-consumer advertising (currently limited)
• Clinical advocacy and partnerships with epilepsy centers
• Development of pediatric formulations (investigational phase)

Regulatory and Patent Landscape

Regulatory Milestones

• FDA approval in 2020 under the 505(b)(2) pathway
• Orphan drug designation granted in some jurisdictions to incentivize development

Patent Protection

• Original formulation protected until 2030
• Pending patents related to delivery device and formulation enhancements

Pricing and Reimbursement

• Wholesaler acquisition cost: Approximately $2,000 per 4-dose carton
• Insurance coverage varies; most payers reimburse for approved indications
• Patient assistance programs offset out-of-pocket costs for eligible patients

Strategic Outlook

Market Expansion Opportunities

• Broader label expansion to include other seizure types
• Pediatric approval extension for ages 6-11
• International regulatory submissions, especially in Europe and Asian markets

R&D Pipeline and Product Line Extensions

• Development of new formulations (e.g., auto-injectors)
• Combination therapies for broader seizure management
• Investigational use in other acute neurological conditions

Competitive Positioning

• NAYZILAM’s minimal invasive nasal spray offers a quick, easy option for emergency seizure management, differentiating it from rectal gels and injectables.
• Market share will depend on prescriber adoption, insurance coverage, and ongoing clinical evidence.

Key Takeaways

• NAYZILAM entered a competitive rescue medication market with established players.
• Sales are projecting steady growth driven by increased awareness and expanded indications.
• Pricing remains a challenge, with reimbursement policies critical to market penetration.
• International and pediatric approvals represent significant growth avenues.
• Clinical and device innovations will influence long-term market positioning.

FAQs

1. How does NAYZILAM differ from other seizure rescue drugs?
It is a nasal spray that provides rapid absorption and easy administration, offering a non-invasive alternative to rectal gels and injections.

2. What are the key regulatory hurdles for NAYZILAM?
Achieving broader indications, pediatric approvals, and addressing competitive pricing pressures.

3. What is the projected global market for NAYZILAM by 2025?
Estimates suggest $80–$100 million, contingent on international approvals and adoption rates.

4. Will insurance reimburse NAYZILAM at competitive rates?
Most major payers provide coverage; however, reimbursement varies and impacts patient access.

5. Are there upcoming clinical trials for NAYZILAM?
Investigations into pediatric use, alternative formulations, and off-label applications are ongoing.

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References

[1] U.S. Food and Drug Administration. (2020). FDA approves first nasal spray medication for emergency treatment of epileptic seizures.
[2] MarketResearch.com. (2022). Epilepsy market analysis.
[3] EvaluatePharma. (2022). Prescription drug sales forecast.