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Last Updated: May 28, 2022

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. 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

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Drug patent expirations by year for NAYZILAM
Drug Prices for NAYZILAM

See drug prices for NAYZILAM

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NAYZILAM
Generic Entry 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:
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 ClassBenzodiazepine
Anatomical Therapeutic Chemical (ATC) Classes for NAYZILAM
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NAYZILAM is See Plans and Pricing.

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

Methods and compositions for the delivery of a therapeutic agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the delivery of a therapeutic agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.