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Last Updated: June 21, 2021

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SUNOSI Drug 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 eight patents protecting this drug.

This drug has forty-one 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:41
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 3
Patent Applications: 78
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

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

Supplementary Protection Certificates for SUNOSI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 2090011-4 Sweden   Get Started Free PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 14/2020 Austria   Get Started Free PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, VORZUGSWEISE EIN HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1408 (MITTEILUNG) 20200120
1890684 C202030015 Spain   Get Started Free 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
1890684 2020/012 Ireland   Get Started Free PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684 2020C/004 Belgium   Get Started Free 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 CA 2020 00016 Denmark   Get Started Free PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 CR 2020 00016 Denmark   Get Started Free PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET HYDROCHLORIDSALT DERAF; REG. 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
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Colorcon

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