SUNOSI Drug Patent Profile
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When do Sunosi patents expire, and what generic alternatives are available?
Sunosi is a drug marketed by Axsome Malta and is included in one NDA. There are thirty-five patents protecting this drug and one Paragraph IV challenge.
This drug has seventy patent family members in twenty-three 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SUNOSI?
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- What is Average Wholesale Price for SUNOSI?
Summary for SUNOSI
| International Patents: | 70 |
| US Patents: | 35 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 5 |
| Patent Applications: | 99 |
| 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
*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 |
|---|---|
| National Multiple Sclerosis Society | Phase 2 |
| Axsome Therapeutics, Inc. | Phase 2 |
| Johns Hopkins University | Phase 2 |
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 thirty-five US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SUNOSI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatment of sleep-wake disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MODERATE OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING A HISTORY OF BIPOLAR DISORDERS AND MODERATE OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-001 | Jun 17, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: Formulations of ( R)-2-amino-3-phenylpropyl carbamate
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 36068
Patent: FORMULATIONS DE (R)-2-AMINO-3-PHENYLPROPYL-CARBAMATE (FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 19000571
Patent: Formulaciones de carbamato de (r) -2-amino-3-fenilpropilo.
Estimated Expiration: ⤷ Sign Up
China
Patent: 9906078
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 09581
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 09581
Patent: FORMULATIONS DE (R (FORMULATIONS OF (R)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 09581
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5193
Patent: פורמולות של (r) -2- אמינו - 3- פאנילפרופיל קארבאמאט (Formulations of (r)-2-amino-3-phenylpropyl carbamate)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 48498
Estimated Expiration: ⤷ Sign Up
Patent: 19533640
Patent: （Ｒ）−２−アミノ−３−フェニルプロピルカルバメートの製剤
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 7631
Patent: FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 19002606
Patent: FORMULACIONES DE (R)-2-AMINO-3-FENILPROPIL CARBAMATO. (FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE.)
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 019500494
Patent: FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 64576
Patent: СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛКАРБАМАТА ((R)-2-AMINO-3-PHENYLPROPYL CARBAMATE FORMULAS)
Estimated Expiration: ⤷ Sign Up
Patent: 19110127
Patent: СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛ КАРБАМАТА
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 9401246
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201901996U
Patent: FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2464646
Estimated Expiration: ⤷ Sign Up
Patent: 190104510
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 37795
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 2018278332 | Methods and compositions for treating excessive sleepiness | ⤷ Sign Up |
| China | 111201014 | 治疗过度嗜睡的方法和组合物 (METHODS AND COMPOSITIONS FOR TREATING EXCESSIVE SLEEPINESS) | ⤷ Sign Up |
| Spain | 2937795 | ⤷ Sign Up | |
| South Korea | 20080035565 | TREATMENT OF SLEEP-WAKE DISORDERS | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 | 132020000000040 | Italy | ⤷ Sign Up | PRODUCT NAME: SOLRIAMFETOL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, PREFERIBILMENTE UN SUO SALE CLORIDRATO(SUNOSI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1408, 20200120 |
| 1890684 | SPC/GB20/017 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTERED: UK EU/1/19/1408 (NI) 20200120; UK PLGB 31626/0003 20200120; UK PLGB 31626/0002 20200120 |
| 1890684 | C202030015 | Spain | ⤷ Sign Up | PRODUCT NAME: SOLRIAMFETOL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PREFERIBLEMENTE UNA SAL DE CLORHIDRATO DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1408; DATE OF AUTHORISATION: 20200116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1408; DATE OF FIRST AUTHORISATION IN EEA: 20200116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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