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Last Updated: July 2, 2020

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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 six patents protecting this drug.

This drug has thirty patent family members in eighteen 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.

US ANDA Litigation and 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:30
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 5
Patent Applications: 31
Drug Prices: Drug price information for SUNOSI
DailyMed Link:SUNOSI at DailyMed
Drug patent expirations by year for SUNOSI
Drug Prices for SUNOSI

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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.

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   Start Trial   Start Trial   Start Trial
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Jazz SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
>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 CA 2020 00016 Denmark   Start Trial PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 301037 Netherlands   Start Trial PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR HET HYDROCHLORIDEZOUT DAARVAN; 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

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.