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Last Updated: June 27, 2022

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 Jazz and is included in one NDA. There are nine patents protecting this drug.

This drug has forty-two patent family members in nineteen 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 will be eligible for patent challenges on June 17, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for SUNOSI
International Patents:42
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 15
Clinical Trials: 4
Patent Applications: 95
Drug Prices: Drug price information for SUNOSI
What excipients (inactive ingredients) are in SUNOSI?SUNOSI excipients list
DailyMed Link:SUNOSI at DailyMed
Drug patent expirations by year for SUNOSI
Drug Prices for SUNOSI

See drug prices for SUNOSI

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
Charles Andrew Czeisler, MD, PhDPhase 4
Rochester Center for Behavioral MedicinePhase 4
Jazz PharmaceuticalsPhase 4

See all SUNOSI clinical trials

US Patents and Regulatory Information for SUNOSI

SUNOSI is protected by nine US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SUNOSI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of sleep-wake disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Treatment of sleep-wake disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Canada

Patent: 36068
Estimated Expiration: See Plans and Pricing

Chile

Patent: 19000571
Estimated Expiration: See Plans and Pricing

China

Patent: 9906078
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 09581
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5193
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19533640
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 19002606
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 019500494
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 64576
Estimated Expiration: See Plans and Pricing

Patent: 19110127
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201901996U
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190104510
Estimated Expiration: See Plans and Pricing

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
Netherlands 301037 See Plans and Pricing
Taiwan 201328689 Method for treating sleep-wake disorders See Plans and Pricing
South Korea 20200016889 과다 졸림증을 치료하기 위한 방법 및 조성물 See Plans and Pricing
China 101217949 Treatment of sleep-wake disorders See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUNOSI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 CA 2020 00016 Denmark See Plans and Pricing PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 2020C/004 Belgium See Plans and Pricing 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 2020/012 Ireland See Plans and Pricing PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684 20C1014 France See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Moodys
Dow
Boehringer Ingelheim
Colorcon

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