SUNOSI Drug Patent Profile

When do Sunosi patents expire, and what generic alternatives are available?

Sunosi is a drug marketed by Axsome Malta and is included in one NDA. There are forty-two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SUNOSI is solriamfetol hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the solriamfetol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sunosi

A generic version of SUNOSI was approved as solriamfetol hydrochloride by ALKEM LABS LTD on June 17^th, 2026.

Summary for SUNOSI

US Patents:	42
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	5
Drug Prices:	Drug price information for SUNOSI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUNOSI
What excipients (inactive ingredients) are in SUNOSI?	SUNOSI excipients list
DailyMed Link:	SUNOSI at DailyMed

See drug prices for SUNOSI

Recent Clinical Trials for SUNOSI

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

Sponsor	Phase
Axsome Therapeutics, Inc.	Phase 2
Johns Hopkins University	Phase 2
National Multiple Sclerosis Society	Phase 2

See all SUNOSI clinical trials

Pharmacology for SUNOSI

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

Paragraph IV (Patent) Challenges for SUNOSI

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 SUNOSI

SUNOSI is protected by forty-two US patents and one FDA Regulatory Exclusivity.

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	11,850,227
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	RX	Yes	No	11,439,597		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	RX	Yes	No	11,850,228
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	AB	RX	Yes	Yes	11,560,354		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	AB	RX	Yes	Yes	11,771,667
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	AB	RX	Yes	Yes	8,440,715

Expired US Patents for SUNOSI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	9,604,917
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	10,351,517
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	8,877,806
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	10,351,517
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	8,877,806
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	9,604,917

International Patents for SUNOSI

When does loss-of-exclusivity occur for SUNOSI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Chile

China

Denmark

European Patent Office

Finland

Israel

Japan

Malaysia

Mexico

New Zealand

Philippines

Russian Federation

Saudi Arabia

Singapore

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SUNOSI around the world.

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

Supplementary Protection Certificates for SUNOSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1890684	301037	Netherlands		PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR HET HYDROCHLORIDEZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684	CA 2020 00016	Denmark		PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684	122020000015	Germany		PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
1890684	132020000000040	Italy		PRODUCT NAME: SOLRIAMFETOL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, PREFERIBILMENTE UN SUO SALE CLORIDRATO(SUNOSI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1408, 20200120
1890684	2020C/004	Belgium		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	2090011-4	Sweden		PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120

DrugChatter Q&A for SUNOSI

Sunosi patentschutz?
Sunosi loss of exclusivity?
Sunosi approval date?
Sunosi dosing?