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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. Five suppliers are listed for this compound. Additional details are available on the midazolam profile page.

DrugPatentWatch^® Generic Entry Outlook for Nayzilam

There have been two 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:	4,699
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

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/002267 Treatment 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

NAYZILAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NAYZILAM

Overview of NAYZILAM

NAYZILAM, developed by UCB, is a midazolam nasal spray approved by the U.S. FDA for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, known as seizure clusters or acute repetitive seizures, in patients with epilepsy aged 12 years and older[3].

Market Size and Growth

The global acute repetitive seizures market, in which NAYZILAM is a key player, was estimated at USD 2.60 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 12.4% from 2023 to 2030, reaching USD 6.31 billion by 2030[1].

Product Segment Performance

NAYZILAM (USL-261) dominated the acute repetitive seizures market in 2022, primarily due to its intranasal delivery method, which allows caregivers to administer the drug without the need for a needle. This convenience and rapid action have contributed significantly to its market share[1].

Regional Outlook

The Asia Pacific region is expected to be a significant growth driver for NAYZILAM, with a projected CAGR of 13.8% over the forecast period. This growth is driven by increased healthcare expenditure in developing countries such as India and China, where there is a high prevalence of epilepsy and a substantial gap in treating acute repetitive seizures[1].

Extended Shelf Life Approval

Recently, the U.S. FDA approved an extended shelf life for NAYZILAM from 12 to 24 months, based on new drug stability data provided by UCB. This extended shelf life enhances the product's viability and convenience for patients and caregivers[3].

Financial Performance

NAYZILAM has contributed significantly to UCB's financial performance. In FY 2023, NAYZILAM reached net sales of € 94 million, representing a 21% increase (24% at constant exchange rates) compared to the previous year. This growth is part of UCB's overall strong performance driven by its growth assets, including BRIVIACT, FINTEPLA, and BIMZELX[5].

Competitive Landscape

UCB and Neurelis, Inc. are expected to hold major shares of the global acute repetitive seizures market due to the commercialization of NAYZILAM and VALTOCO, respectively. The preference for nasal administration routes, such as NAYZILAM, is expected to drive higher adoption rates for these drugs[1].

Business Expansion Strategies

Companies in the acute repetitive seizures market, including UCB, are focusing on business expansion strategies such as novel product launches, acquisitions, and collaborations. For example, Neurelis signed an exclusive agreement with Aculys Pharma to commercialize and develop VALTOCO in the Asia Pacific region, highlighting the strategic importance of regional partnerships[1].

Future Growth Prospects

UCB is on a growth path for over a decade, driven by strong product launches and a robust pipeline. The company plans to accelerate investments in launching new products globally, including a direct-to-consumer campaign for BIMZELX in the U.S. This strategic focus on growth and innovation is expected to further boost NAYZILAM's market position[5].

Nasal Drug Delivery Market Context

The broader nasal drug delivery market, in which NAYZILAM operates, is also experiencing significant growth. This market is projected to grow from USD 3.6 billion in 2023 to USD 26.8 billion by 2035, with a CAGR of 18.3%. The dominance of North America in this market is attributed to robust healthcare infrastructure and advanced research facilities, but the Asia Pacific region is emerging as a rapid growth area[4].

Key Takeaways

• Market Growth: The acute repetitive seizures market is expected to grow at a CAGR of 12.4% from 2023 to 2030.
• Product Dominance: NAYZILAM dominated the market in 2022 due to its intranasal delivery method.
• Regional Growth: The Asia Pacific region is a key growth area due to increased healthcare expenditure.
• Extended Shelf Life: NAYZILAM's shelf life has been extended to 24 months, enhancing its convenience.
• Financial Performance: NAYZILAM contributed significantly to UCB's net sales in FY 2023.
• Competitive Landscape: UCB and Neurelis are major players in the market.
• Future Prospects: UCB's strategic focus on growth and innovation is expected to boost NAYZILAM's market position.

FAQs

What is NAYZILAM used for?

NAYZILAM is used for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters or acute repetitive seizures) in patients with epilepsy aged 12 years and older[3].

How is NAYZILAM administered?

NAYZILAM is administered via an intranasal spray, allowing caregivers to administer the drug without the need for a needle[1].

What is the projected market size for the acute repetitive seizures market by 2030?

The global acute repetitive seizures market is expected to reach USD 6.31 billion by 2030, growing at a CAGR of 12.4% from 2023 to 2030[1].

Which region is expected to drive the growth of NAYZILAM?

The Asia Pacific region is expected to be a significant growth driver for NAYZILAM due to increased healthcare expenditure in developing countries such as India and China[1].

What is the current shelf life of NAYZILAM?

The U.S. FDA has approved an extended shelf life for NAYZILAM from 12 to 24 months based on new drug stability data[3].

Sources

1. Grand View Research - Acute Repetitive Seizures Market Size & Share Report, 2030
2. UCB USA - UCB on Growth Path for a Decade Plus
3. Dup15Q Alliance - NAYZILAM gets extended shelf life approval
4. Roots Analysis - Nasal Drug Delivery Market Size, Growth & Analysis 2035
5. PR Newswire - UCB on Growth Path for a Decade Plus