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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 211230


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NDA 211230 describes SUNOSI, which is a drug marketed by Jazz and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the SUNOSI profile page.

The generic ingredient in SUNOSI is solriamfetol hydrochloride. One supplier is listed for this compound. Additional details are available on the solriamfetol hydrochloride profile page.
Summary for 211230
Tradename:SUNOSI
Applicant:Jazz
Ingredient:solriamfetol hydrochloride
Patents:6
Generic Entry Opportunity Date for 211230
Generic Entry Date for 211230*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

Suppliers and Packaging for NDA: 211230
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230 NDA Jazz Pharmaceuticals, Inc. 68727-350 68727-350-01 30 TABLET, FILM COATED in 1 BOTTLE (68727-350-01)
SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230 NDA Jazz Pharmaceuticals, Inc. 68727-350 68727-350-02 100 TABLET, FILM COATED in 1 BOTTLE (68727-350-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Jun 17, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 17, 2026
Regulatory Exclusivity Use:INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
Regulatory Exclusivity Expiration:Jun 17, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Sep 5, 2037Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
McKinsey
Baxter
Boehringer Ingelheim
Medtronic

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.