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Last Updated: August 17, 2022

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 Axsome Malta and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Solriamfetol hydrochloride has forty-two patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for solriamfetol hydrochloride
Recent Clinical Trials for solriamfetol hydrochloride

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

SponsorPhase
Charles Andrew Czeisler, MD, PhDPhase 4
Massachusetts General HospitalPhase 2/Phase 3
Rochester Center for Behavioral MedicinePhase 4

See all solriamfetol hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for solriamfetol hydrochloride

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
Axsome Malta 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
Axsome Malta 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
Axsome Malta 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

Supplementary Protection Certificates for solriamfetol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 C202030015 Spain See Plans and Pricing 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 2090011-4 Sweden See Plans and Pricing PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 301037 Netherlands See Plans and Pricing 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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