Last Updated: July 2, 2026

Solriamfetol - Generic Drug Details

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Summary for Solriamfetol

International Patents:	30
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	1
Patent Applications:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Solriamfetol
What excipients (inactive ingredients) are in Solriamfetol?	Solriamfetol excipients list
DailyMed Link:	Solriamfetol at DailyMed

Recent Clinical Trials for Solriamfetol

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

Sponsor	Phase
University Hospital, Montpellier	PHASE2
Duke University	PHASE2
Axsome Therapeutics, Inc.	Phase 2

See all Solriamfetol clinical trials

Generic filers with tentative approvals for SOLRIAMFETOL

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	150MG	TABLET
⤷ Start Trial	⤷ Start Trial	75MG	TABLET
⤷ Start Trial	⤷ Start Trial	300MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for Solriamfetol

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

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