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Last Updated: April 22, 2024

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 twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Solriamfetol hydrochloride has sixty-five patent family members in twenty-two countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for solriamfetol hydrochloride
Generic Entry Date for solriamfetol hydrochloride*:
Constraining patent/regulatory exclusivity:
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 solriamfetol hydrochloride

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

SponsorPhase
Axsome Therapeutics, Inc.Phase 4
University of PennsylvaniaPhase 4
Charles Andrew Czeisler, MD, PhDPhase 4

See all solriamfetol hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for solriamfetol hydrochloride
Paragraph IV (Patent) Challenges for SOLRIAMFETOL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUNOSI Tablets solriamfetol hydrochloride 75 mg and 150 mg 211230 6 2023-06-20

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 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 3509582 FORME DE SOLVATE DE CARBAMATE DE (R) -2-AMINO-3-PHÉNYLPROPYLE (SOLVATE FORM OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE) ⤷  Try a Trial
South Korea 20080035565 TREATMENT OF SLEEP-WAKE DISORDERS ⤷  Try a Trial
Australia 2006254899 Treatment of sleep-wake disorders ⤷  Try a Trial
Russian Federation 2008100019 СПОСОБ ЛЕЧЕНИЯ ЧРЕЗМЕРНОЙ ДНЕВНОЙ СОНЛИВОСТИ (ВАРИАНТЫ) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for solriamfetol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 C202030015 Spain ⤷  Try a Trial 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 301037 Netherlands ⤷  Try a Trial PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR HET HYDROCHLORIDEZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684 2020C/004 Belgium ⤷  Try a Trial 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 20C1014 France ⤷  Try a Trial PRODUCT NAME: SOLRIAMFETOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, DE PREFERENCE UN SEL DE CHLORHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1408 20200120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.