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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211321


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NDA 211321 describes NAYZILAM, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NAYZILAM profile page.

The generic ingredient in NAYZILAM is midazolam. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the midazolam profile page.
Summary for 211321
Tradename:NAYZILAM
Applicant:Ucb Inc
Ingredient:midazolam
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 211321
Generic Entry Date for 211321*:
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
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 NDA: 211321
Suppliers and Packaging for NDA: 211321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAYZILAM midazolam SPRAY;NASAL 211321 NDA UCB, Inc. 50474-500 50474-500-15 2 BLISTER PACK in 1 CARTON (50474-500-15) > 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) > .1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:May 17, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:May 17, 2026
Regulatory Exclusivity 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
Regulatory Exclusivity Expiration:May 21, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jan 18, 2028Product Flag?YSubstance Flag?Delist Request?
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

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