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Last Updated: July 16, 2024

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NAYZILAM Drug Patent Profile


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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. Four 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

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Drug patent expirations by year for NAYZILAM
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Pharmacology for NAYZILAM
Drug ClassBenzodiazepine
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.

Patents protecting NAYZILAM

Methods and compositions for the delivery of a therapeutic agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: 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

Methods and compositions for the delivery of a therapeutic agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods and compositions for the delivery of a therapeutic agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: 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

Methods and systems for the delivery of a therapeutic agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: 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

FDA Regulatory Exclusivity protecting NAYZILAM

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
Exclusivity Expiration: ⤷  Sign Up

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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