Last Updated: November 4, 2026

Solriamfetol hydrochloride - Generic Drug Details

Name: solriamfetol hydrochloride Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 two branded drugs marketed by Alkem Labs Ltd, Hikma, and Axsome Malta, and is included in three NDAs. There are forty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for solriamfetol hydrochloride

International Patents:	99
US Patents:	42
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for solriamfetol hydrochloride
DailyMed Link:	solriamfetol hydrochloride at DailyMed

Recent Clinical Trials for solriamfetol hydrochloride

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

Sponsor	Phase
University Hospital, Montpellier	PHASE2
Duke University	PHASE2
Johns Hopkins University	Phase 2

See all solriamfetol hydrochloride clinical trials

Pharmacology for solriamfetol hydrochloride

Drug Class	Dopamine and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for solriamfetol hydrochloride

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Glossary

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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	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	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

Expired US Patents for solriamfetol hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	⤷ Start Trial	⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	⤷ Start Trial	⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	⤷ Start Trial	⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	⤷ Start Trial	⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	⤷ Start Trial	⤷ Start Trial
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for solriamfetol hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Australia	2017324855		⤷ Start Trial
Canada	3036068		⤷ Start Trial
Chile	2019000571		⤷ Start Trial
China	109906078		⤷ Start Trial
Denmark	3509581		⤷ Start Trial
European Patent Office	3509581		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for solriamfetol hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1890684	2020C/004	Belgium	⤷ Start 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	2020/012	Ireland	⤷ Start Trial	PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684	SPC/GB20/017	United Kingdom	⤷ Start Trial	PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTERED: UK EU/1/19/1408 (NI) 20200120; UK PLGB 31626/0003 20200120; UK PLGB 31626/0002 20200120
1890684	CR 2020 00016	Denmark	⤷ Start Trial	PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684	20C1014	France	⤷ Start 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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