SUNOSI Drug Patent Profile
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Which patents cover Sunosi, and when can generic versions of Sunosi launch?
Sunosi is a drug marketed by Axsome Malta and is included in one NDA. There are twenty-seven patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-five patent family members in twenty-two countries.
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.
DrugPatentWatch® Generic Entry Outlook for Sunosi
Sunosi was eligible for patent challenges on June 17, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 5, 2037. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SUNOSI
| International Patents: | 65 |
| US Patents: | 27 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 4 |
| Patent Applications: | 49 |
| Drug Prices: | Drug price information for SUNOSI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUNOSI |
| What excipients (inactive ingredients) are in SUNOSI? | SUNOSI excipients list |
| DailyMed Link: | SUNOSI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SUNOSI
Generic Entry Date for SUNOSI*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for SUNOSI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Charles Andrew Czeisler, MD, PhD | Phase 4 |
| Rochester Center for Behavioral Medicine | Phase 4 |
| Lindner Center of HOPE | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for SUNOSI
Paragraph IV (Patent) Challenges for SUNOSI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SUNOSI | Tablets | solriamfetol hydrochloride | 75 mg and 150 mg | 211230 | 6 | 2023-06-20 |
US Patents and Regulatory Information for SUNOSI
SUNOSI is protected by twenty-seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SUNOSI is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SUNOSI
Formulations of (R)-2-amino-3-phenylpropyl carbamate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Treatment of sleep-wake disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Formulations of (R)-2-amino-3-phenylpropyl carbamate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Methods and compositions for treating excessive sleepiness
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of providing solriamfetol therapy to subjects with impaired renal function
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN A PATIENT WITH MODERATE RENAL IMPAIRMENT
Methods and compositions for treating excessive sleepiness
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of providing solriamfetol therapy to subjects with impaired renal function
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Formulations of (R)-2-amino-3-phenylpropyl carbamate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING A COMPOSITION COMPRISING SOLRIAMFETOL HYDROCHLORIDE AND 2-CHLOROPROPANE, WHEREIN THE COMPOSITION COMPRISES LESS THAN ABOUT 5 PPM 2‑CHLOROPROPANE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS WITH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MODERATE OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING OBSTRUCTIVE SLEEP APNEA (OSA) AND NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Treatment of sleep-wake disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Treatment of sleep-wake disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Treatment of sleep-wake disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
FDA Regulatory Exclusivity protecting SUNOSI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SUNOSI
When does loss-of-exclusivity occur for SUNOSI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 17324855
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 36068
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 19000571
Estimated Expiration: ⤷ Try a Trial
China
Patent: 9906078
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 09581
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 09581
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 09581
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5193
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 48498
Estimated Expiration: ⤷ Try a Trial
Patent: 19533640
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 7631
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 19002606
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 019500494
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 64576
Estimated Expiration: ⤷ Try a Trial
Patent: 19110127
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201901996U
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2464646
Estimated Expiration: ⤷ Try a Trial
Patent: 190104510
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 37795
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering SUNOSI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2937795 | ⤷ Try a Trial | |
| Denmark | 3509582 | ⤷ Try a Trial | |
| Japan | 2019535643 | （Ｒ）−２−アミノ−３−フェニルプロピルカルバメートの溶媒和物フォーム | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SUNOSI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1890684 | 20C1014 | France | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, DE PREFERENCE UN SEL DE CHLORHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1408 20200120 |
| 1890684 | 2020C/004 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN HYDROCHLORIDE ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1408 20200120 |
| 1890684 | C01890684/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOLUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68177 22.03.2022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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