Pharsight

Sunosi is owned by Jazz.

Sunosi contains Solriamfetol Hydrochloride.

Sunosi has a total of 9 drug patents out of which 0 drug patents have expired.

Sunosi was authorised for market use on 17 June, 2019.

Sunosi is available in tablet;oral dosage forms.

Sunosi can be used as to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa), to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily, treatment of excessive daytime sleepiness associated with obstructive sleep apnea (osa) in a patient with moderate renal impairment, treatment of excessive daytime sleepiness associated with obstructive sleep apnea (osa) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily.

Drug patent challenges can be filed against Sunosi from June, 2023.

The generics of Sunosi are possible to be released after 19 March, 2040.

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8877806	JAZZ	Treatment of sleep-wake disorders	Jun, 2026 (3 years from now)
US9604917	JAZZ	Treatment of sleep-wake disorders	Jun, 2026 (3 years from now)
US10351517	JAZZ	Treatment of sleep-wake disorders	Jun, 2026 (3 years from now)
US8440715	JAZZ	Treatment of sleep-wake disorders	Aug, 2027 (4 years from now)
US10512609	JAZZ	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (14 years from now)
US10195151	JAZZ	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (14 years from now)
US10912754	JAZZ	Methods and compositions for treating excessive sleepiness	Jun, 2038 (15 years from now)
US10959976	JAZZ	Methods and compositions for treating excessive sleepiness	Jun, 2038 (15 years from now)
US10940133	JAZZ	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jun 17, 2024
Orphan Drug Exclusivity (ODE)	Jun 17, 2026

Drugs and Companies using SOLRIAMFETOL HYDROCHLORIDE ingredient

NCE-1 date: June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa); Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (osa) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily; To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily; Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (osa) in a patient with moderate renal impairment

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 75MG BASE	TABLET;ORAL	Prescription
EQ 150MG BASE	TABLET;ORAL	Prescription

Sunosi is owned by Axsome Malta.

Sunosi contains Solriamfetol Hydrochloride.

Sunosi has a total of 1 drug patent out of which 0 drug patents have expired.

Sunosi was authorised for market use on 17 June, 2019.

Sunosi is available in tablet;oral dosage forms.

Drug patent challenges can be filed against Sunosi from June, 2023.

The generics of Sunosi are possible to be released after 05 November, 2034.

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11439597	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Nov, 2034 (11 years from now)