Pharsight

1. List of Sunosi drug patents

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).
US10351517	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)
US8877806	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

2. List of Xywav drug patents

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).
US8731963	JAZZ	Sensitive drug distribution system and method	Dec, 2022 (a month ago)
US8731963 (Pediatric)	JAZZ	Sensitive drug distribution system and method	Jun, 2023 (4 months from now)
US9132107	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (9 years from now)
US10675258	JAZZ	Method of using gamma-hydroxybutyrate compositions for the treatment of disorders	Jan, 2033 (9 years from now)
US8901173	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (9 years from now)
US10195168	JAZZ	Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders	Jan, 2033 (9 years from now)
US8591922	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (9 years from now)
US9486426	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (10 years from now)
US10864181	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (10 years from now)
US11253494	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (10 years from now)
US8772306	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (10 years from now)
US10213400	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (10 years from now)
US9050302	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (10 years from now)
US10864181 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US9486426 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US11253494 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US9050302 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US10213400 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US8772306 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US11426373	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Sep, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Aug 12, 2028
New Product (NP)	Jul 21, 2023
New Indication (I)	Aug 12, 2024

Drugs and Companies using CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE ingredient

Market Authorisation Date: 21 July, 2020

Treatment: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution; Treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb; Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.; Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered; Method of reducing adverse effects in patients who are concomitantly administered a salt of gamma-hydroxybutyrate and divalproex sodium; Method of treating patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered; Method of treating patients with idiopathic hypersomnia with sodium oxybate when divalproex sodium is concomitantly administered; Method of reducing adverse effects in patients suffering from excessive daytime sleepiness and/or cataplexy in narcolepsy who are concomitantly administered sodium oxybate and divalproex sodium; Treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb administered between 2 and 4 hours after eating

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.234 g/0.096 g/ 013 g/0.04 g per mL	12 Apr, 2021	1		15 Mar, 2033

Strength	Dosage	Availability
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION;ORAL	Prescription

3. List of Zepzelca drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7763615	JAZZ	Ecteinascidin analogs for use as antitumour agents	Dec, 2024 (1 year, 10 months from now)