Sunosi is a drug owned by Axsome Malta Ltd. It is protected by 36 US drug patents filed from 2019 to 2024 out of which none have expired yet. Sunosi's patents have been open to challenges since 18 June, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 30, 2042. Details of Sunosi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12036194 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11872204 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11872203 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US12064411 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US12102609 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11771666 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11771667 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US12090126 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US12005036 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11793776 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11779554 | Methods of administering solriamfetol to lactating women |
Dec, 2042
(18 years from now) | Active |
| US11850226 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11160779 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US10940133 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11839599 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11839598 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11850227 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11850228 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11857528 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11986455 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11986454 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11969404 | Methods of providing solriamfetol therapy to subjects with impaired renal function |
Mar, 2040
(15 years from now) | Active |
| US11560354 | Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof |
Mar, 2039
(14 years from now) | Active |
| US10959976 | Methods and compositions for treating excessive sleepiness |
Jun, 2038
(13 years from now) | Active |
| US10912754 | Methods and compositions for treating excessive sleepiness |
Jun, 2038
(13 years from now) | Active |
| US11648232 | Methods and compositions for treating excessive sleepiness |
Jun, 2038
(13 years from now) | Active |
| US11865098 | Methods and compositions for treating excessive sleepiness |
Jun, 2038
(13 years from now) | Active |
| US10195151 | Formulations of (R)-2-amino-3-phenylpropyl carbamate |
Sep, 2037
(12 years from now) | Active |
| US11998639 | Formulations of (R)-2-amino-3-phenylpropyl carbamate |
Sep, 2037
(12 years from now) | Active |
| US11439597 | Formulations of (R)-2-amino-3-phenylpropyl carbamate |
Sep, 2037
(12 years from now) | Active |
| US10512609 | Formulations of (R)-2-amino-3-phenylpropyl carbamate |
Sep, 2037
(12 years from now) | Active |
| US8440715 | Treatment of sleep-wake disorders |
Jun, 2031
(6 years from now) | Active |
| US11753368 | Treatment of sleep-wake disorders |
Jun, 2026
(1 year, 5 months from now) | Active |
| US10351517 | Treatment of sleep-wake disorders |
Jun, 2026
(1 year, 5 months from now) | Active |
| US8877806 | Treatment of sleep-wake disorders |
Jun, 2026
(1 year, 5 months from now) | Active |
| US9604917 | Treatment of sleep-wake disorders |
Jun, 2026
(1 year, 5 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Sunosi's patents.
Latest Legal Activities on Sunosi's Patents
Given below is the list of recent legal activities going on the following patents of Sunosi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eCofC Notification | 28 May, 2024 | US11969404 |
| Recordation of Patent eCertificate of Correction | 28 May, 2024 | US11969404 |
| Patent eCofC Notification | 28 May, 2024 | US11969404 |
| Email Notification Critical | 28 May, 2024 | US11969404 |
| Mail Patent eCofC Notification | 21 May, 2024 | US11771667 |
| Recordation of Patent eCertificate of Correction | 21 May, 2024 | US11771667 |
| Email Notification Critical | 21 May, 2024 | US11771667 |
| Patent eCofC Notification | 21 May, 2024 | US11771667 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 May, 2024 | US8877806 |
| Email Notification Critical | 03 May, 2024 | US8877806 |
FDA has granted several exclusivities to Sunosi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sunosi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Sunosi.
Exclusivity Information
Sunosi holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Sunosi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 17, 2024 |
| Orphan Drug Exclusivity(ODE-254) | Jun 17, 2026 |
US patents provide insights into the exclusivity only within the United States, but Sunosi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Sunosi's family patents as well as insights into ongoing legal events on those patents.
Sunosi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sunosi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 30, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sunosi Generics:
There are no approved generic versions for Sunosi as of now.
How can I launch a generic of Sunosi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sunosi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sunosi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Sunosi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg and 150 mg | 20 Jun, 2023 | 6 | 19 Mar, 2040 |
About Sunosi
Sunosi is a drug owned by Axsome Malta Ltd. It is used for improving wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea through a dosing regimen that includes oral administration of Solriamfetol. Sunosi uses Solriamfetol Hydrochloride as an active ingredient. Sunosi was launched by Axsome Malta in 2019.
Approval Date:
Sunosi was approved by FDA for market use on 17 June, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Sunosi is 17 June, 2019, its NCE-1 date is estimated to be 18 June, 2023.
Active Ingredient:
Sunosi uses Solriamfetol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Solriamfetol Hydrochloride ingredient
Treatment:
Sunosi is used for improving wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea through a dosing regimen that includes oral administration of Solriamfetol.
Dosage:
Sunosi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | TABLET | Prescription | ORAL |
| EQ 75MG BASE | TABLET | Prescription | ORAL |