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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211635


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NDA 211635 describes VALTOCO, which is a drug marketed by Neurelis Inc and is included in one NDA. There are five patents protecting this drug. Additional details are available on the VALTOCO profile page.

The generic ingredient in VALTOCO is diazepam. There are eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 211635
Tradename:VALTOCO
Applicant:Neurelis Inc
Ingredient:diazepam
Patents:5
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Jan 10, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 10, 2027
Regulatory Exclusivity Use:INDICATED FOR THE ACUTE TX 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 6 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:Jan 10, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:May 11, 2025Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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Colorcon

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