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

DrugPatentWatch^® Generic Entry Outlook for Nayzilam

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 17, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 is one tentative approval 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:	40
Patent Applications:	4,073
Formulation / Manufacturing:	see details
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for NAYZILAM

Constraining patent/regulatory exclusivity:

ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER

NDA:

211321

Dosage:

SPRAY;NASAL

^*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 NAYZILAM

Drug Class

Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for NAYZILAM

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

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 two FDA Regulatory Exclusivities.

This potential generic entry date is based on ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 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.

Patents protecting NAYZILAM

FDA Regulatory Exclusivity protecting NAYZILAM

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
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes