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Last Updated: September 26, 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

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 211230-002 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
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

International Patents for solriamfetol hydrochloride

Country Patent Number Title Estimated Expiration
Taiwan 201328689 Method for treating sleep-wake disorders See Plans and Pricing
World Intellectual Property Organization (WIPO) 2018222954 See Plans and Pricing
Russian Federation 2764576 СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛКАРБАМАТА ((R)-2-AMINO-3-PHENYLPROPYL CARBAMATE FORMULAS) See Plans and Pricing
Taiwan I419681 See Plans and Pricing
South Korea 20190104510 (R)-2-아미노-3-페닐프로필 카바메이트의 제제 See Plans and Pricing
Russian Federation 2008100019 СПОСОБ ЛЕЧЕНИЯ ЧРЕЗМЕРНОЙ ДНЕВНОЙ СОНЛИВОСТИ (ВАРИАНТЫ) See Plans and Pricing
South Korea 20080035565 TREATMENT OF SLEEP-WAKE DISORDERS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for solriamfetol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C01890684/01 Switzerland See Plans and Pricing PRODUCT NAME: SOLRIAMFETOLUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68177 22.03.2022
1890684 CR 2020 00016 Denmark See Plans and Pricing PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS 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 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
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 122020000015 Germany See Plans and Pricing 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:

Boehringer Ingelheim
Express Scripts
Merck
Colorcon
Mallinckrodt
Dow

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