Excessive Daytime Sleepiness In Narcolepsy Therapeutics

1. Sunosi patent expiration

Treatment: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa); Treatment of excessive daytime sleepiness in a breast-feeding pa...

SUNOSI IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US12384743 AXSOME MALTA NA
Nov, 2038

(12 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8440715 AXSOME MALTA Treatment of sleep-wake disorders
Jun, 2031

(5 years from now)

US12209059 AXSOME MALTA Treatment of sleep-wake disorders
Jun, 2026

(4 months from now)

US12390419 AXSOME MALTA NA
Sep, 2037

(11 years from now)

US12090126 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11753368 AXSOME MALTA Treatment of sleep-wake disorders
Jun, 2026

(4 months from now)

US11998639 AXSOME MALTA Formulations of (R)-2-amino-3-phenylpropyl carbamate
Sep, 2037

(11 years from now)

US12263145 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US12318362 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11969404 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US12194016 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US10940133 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11771666 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US10512609 AXSOME MALTA Formulations of (R)-2-amino-3-phenylpropyl carbamate
Sep, 2037

(11 years from now)

US11779554 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US10351517 AXSOME MALTA Treatment of sleep-wake disorders
Jun, 2026

(4 months from now)

US12036194 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11560354 AXSOME MALTA Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof
Mar, 2039

(13 years from now)

US11160779 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11771667 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US8877806 AXSOME MALTA Treatment of sleep-wake disorders
Jun, 2026

(4 months from now)

US12064411 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11793776 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US10959976 AXSOME MALTA Methods and compositions for treating excessive sleepiness
Jun, 2038

(12 years from now)

US10912754 AXSOME MALTA Methods and compositions for treating excessive sleepiness
Jun, 2038

(12 years from now)

US11648232 AXSOME MALTA Methods and compositions for treating excessive sleepiness
Jun, 2038

(12 years from now)

US11865098 AXSOME MALTA Methods and compositions for treating excessive sleepiness
Jun, 2038

(12 years from now)

US11839599 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11839598 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11850227 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11850228 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11857528 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11872203 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11872204 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11986454 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US12005036 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11850226 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US11986455 AXSOME MALTA Methods of providing solriamfetol therapy to subjects with impaired renal function
Mar, 2040

(14 years from now)

US12102609 AXSOME MALTA Methods of administering solriamfetol to lactating women
Dec, 2042

(16 years from now)

US11439597 AXSOME MALTA Formulations of (R)-2-amino-3-phenylpropyl carbamate
Sep, 2037

(11 years from now)

US10195151 AXSOME MALTA Formulations of (R)-2-amino-3-phenylpropyl carbamate
Sep, 2037

(11 years from now)

US9604917 AXSOME MALTA Treatment of sleep-wake disorders
Jun, 2026

(4 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 17, 2024
Orphan Drug Exclusivity(ODE-254) Jun 17, 2026

Drugs and Companies using SOLRIAMFETOL HYDROCHLORIDE ingredient

NCE-1 date: 18 June, 2023

Market Authorisation Date: 17 June, 2019

Dosage: TABLET

How can I launch a generic of SUNOSI before it's drug patent expiration?
More Information on Dosage

SUNOSI family patents

Family Patents

2. Xyrem patent expiration

Treatment: Method of treating cataplexy in patients with narcolepsy; Method of treating a patient with a prescription drug using a computer database in a computer system for distribution; Method of treating exce...

XYREM's oppositions filed in EPO
XYREM IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9539330

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(5 years ago)

US8952062 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(6 years ago)

US8589182 JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2022

(3 years ago)

US8731963 JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2022

(3 years ago)

US8731963

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2023

(2 years ago)

US8263650 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(6 years ago)

US6780889

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jan, 2021

(5 years ago)

US7262219

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jan, 2021

(5 years ago)

US7765107

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2024

(1 year, 23 days ago)

US7895059

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2023

(2 years ago)

US8457988

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2023

(2 years ago)

US7262219 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jul, 2020

(5 years ago)

US7765106

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2024

(1 year, 23 days ago)

US8859619 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(6 years ago)

US8589182

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2023

(2 years ago)

US7851506

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(5 years ago)

US8263650

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(5 years ago)

US8324275

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(5 years ago)

US8859619

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(5 years ago)

US8952062

(Pediatric)

JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(5 years ago)

US9539330 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(6 years ago)

US8457988 JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2022

(3 years ago)

US8324275 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(6 years ago)

US7668730 JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2024

(1 year, 6 months ago)

US7668730

(Pediatric)

JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2024

(1 year, 23 days ago)

US7895059 JAZZ PHARMS Sensitive drug distribution system and method
Dec, 2022

(3 years ago)

US7851506 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(6 years ago)

US7765107 JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2024

(1 year, 6 months ago)

US7765106 JAZZ PHARMS Sensitive drug distribution system and method
Jun, 2024

(1 year, 6 months ago)

US6780889 JAZZ PHARMS Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jul, 2020

(5 years ago)

US9486426 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US9050302 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US8772306 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US10213400 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US11986446 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US10864181 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US11253494 JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(7 years from now)

US8772306

(Pediatric)

JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(7 years from now)

US9486426

(Pediatric)

JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(7 years from now)

US9050302

(Pediatric)

JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(7 years from now)

US11253494

(Pediatric)

JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(7 years from now)

US10213400

(Pediatric)

JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(7 years from now)

US10864181

(Pediatric)

JAZZ PHARMS Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(7 years from now)




Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) Nov 18, 2012
New Patient Population(NPP) Oct 26, 2021
Orphan Drug Exclusivity(ODE-231) Oct 26, 2025
Pediatric Exclusivity(PED) Apr 26, 2026

Drugs and Companies using SODIUM OXYBATE ingredient

Market Authorisation Date: 17 July, 2002

Dosage: SOLUTION

How can I launch a generic of XYREM before it's drug patent expiration?
More Information on Dosage

XYREM family patents

Family Patents