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Last Updated: August 9, 2020

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SOLRIAMFETOL HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for solriamfetol hydrochloride and what is the scope of freedom to operate?

Solriamfetol hydrochloride is the generic ingredient in one branded drug marketed by Jazz and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Solriamfetol hydrochloride has thirty patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for SOLRIAMFETOL HYDROCHLORIDE
International Patents:30
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 7
Clinical Trials: 1
Patent Applications: 8
DailyMed Link:SOLRIAMFETOL HYDROCHLORIDE at DailyMed
Recent Clinical Trials for SOLRIAMFETOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 2
Wake Forest University Health SciencesPhase 2

See all SOLRIAMFETOL HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for SOLRIAMFETOL HYDROCHLORIDE

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 211230-002 Jun 17, 2019 RX Yes Yes   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 Y   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 SOLRIAMFETOL HYDROCHLORIDE

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
1890684 122020000015 Germany   Start Trial PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Boehringer Ingelheim
McKesson
Moodys
Colorcon

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