Solriamfetol hydrochloride - Generic Drug Details

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.

Solriamfetol hydrochloride has ninety-nine patent family members in twenty-four countries.

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
Axsome Therapeutics, Inc.	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

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

Expired US Patents for solriamfetol hydrochloride

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

International Patents for solriamfetol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2017324855	Formulations of ( R)-2-amino-3-phenylpropyl carbamate
Canada	3036068	FORMULATIONS DE (R)-2-AMINO-3-PHENYLPROPYL-CARBAMATE (FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE)
Chile	2019000571	Formulaciones de carbamato de (r) -2-amino-3-fenilpropilo.
China	109906078	(R)-2-氨基-3-苯丙基氨基甲酸酯的制剂 (FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE)
Denmark	3509581
European Patent Office	3509581	FORMULATIONS DE (R (FORMULATIONS OF (R)
Spain	2937795

Supplementary Protection Certificates for solriamfetol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CR 2020 00016	Denmark		PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS 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	14/2020	Austria		PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, VORZUGSWEISE EIN HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1408 (MITTEILUNG) 20200120
1890684	SPC/GB20/017	United Kingdom		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	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

Last updated: February 16, 2026

What Are the Current Market Dynamics for Solriamfetol Hydrochloride?

Solriamfetol hydrochloride is marketed primarily as a treatment for excessive sleepiness associated with narcolepsy and obstructive sleep apnea. Its dynamics are driven by clinical needs, regulatory pathways, competitive landscape, and patent status.

Market Drivers

• Growing Prevalence: Narcolepsy affects approximately 1 in 2000 individuals globally, with obstructive sleep apnea affecting roughly 1 billion people worldwide, increasing demands for effective wake-promoting agents.
• Unmet Medical Need: Existing treatments have limitations concerning efficacy and side effects, creating a demand for newer medications like solriamfetol.
• Regulatory Approvals: The FDA approved solriamfetol in March 2019, validating its market potential and enabling commercialization.
• Pricing and Reimbursement: Cost-effectiveness analyses and insurance coverage influence prescription rates, with high pricing sustaining revenue but also posing barriers.

Market Challenges

• Competitive Landscape: Other wake-promoting drugs, such as modafinil and armodafinil, dominate the market, with newer agents like pitolisant gaining traction.
• Side Effects and Safety Profile: Cardiovascular risks and mental health side effects influence prescribing behavior.
• Patent Status and Biosimilars: Patent expirations in key markets threaten future exclusivity, which can erode market share.

Market Size and Growth

• Estimated global market size for wakefulness-promoting agents was valued at approximately $800 million in 2022, with a compound annual growth rate (CAGR) forecast of around 7% through 2030 (sources: IQVIA, MarketWatch).

Regional Dynamics

• North America: Largest market, driven by high diagnosis rates and insurance coverage.
• Europe: Moderate growth, constrained by regulatory delays and reimbursement issues.
• Asia-Pacific: Emerging opportunity due to increasing sleep disorder awareness and healthcare infrastructure development.

What Is the Financial Trajectory for Solriamfetol?

Revenue Estimates

• Novartis reported revenues of $300 million for solriamfetol in 2022, comprising approximately 4% of its sleep disorder drug segment.
• The drug's sales are projected to grow at a CAGR of 10–12% over the next five years, reaching $600–$700 million by 2027.

Cost Structure and Profitability

• Development costs for solriamfetol were approximately $250 million, including research, trials, and regulatory filings.
• Margins are affected by patent protections and competition, with net margins estimated around 20% in the current phase.

Patent and Regulatory Impact

• Patents protecting solriamfetol are valid until at least 2027 in major markets; generic competition could emerge post-expiration, affecting pricing and profitability.
• Potential for new formulations or indications could extend market exclusivity.

Investment and R&D Considerations

• Investment in phase III trials for additional indications (e.g., shift work sleep disorder) could bolster long-term revenues.
• Cost of late-stage trials ranges from $50–$100 million per indication.

Licensing, Partnerships, and Market Access

• Strategic partnerships enhance distribution, especially in emerging markets, facilitating revenue growth.
• Market access strategies, including formulary inclusion and reimbursement negotiations, are critical for achieving projected sales.

How Do Market and Financial Factors Interact?

High unmet medical needs and regulatory approval support initial sales growth. Patent protections and patent cliffs influence revenue stability. Competition and evolving safety profiles pressure pricing and margins. Future growth hinges on expanding indications, penetrating emerging markets, and extending patent life or developing proprietary formulations.

Key Takeaways

• The market for solriamfetol is driven by its role in treating narcolepsy and sleep apnea, with global sales projected to roughly double by 2027.
• Revenue depends heavily on patent status, competition, and regional penetration.
• The drug’s financial outlook is positive, contingent on maintaining exclusivity and expanding uses.
• Long-term profitability will likely hinge on successful lifecycle management strategies and market expansion.

FAQs

1. What are the primary competitors to solriamfetol?
Modafinil, armodafinil, and pitolisant are key competitors in the wakefulness agent market.

2. When will generic versions potentially enter the market?
Patent expiration in key markets is expected around 2027, opening the door for generics.

3. Are there any approved off-label uses for solriamfetol?
No, off-label uses remain unapproved and are subject to regulatory scrutiny.

4. How do safety concerns affect market penetration?
Cardiovascular and mental health side effects can limit prescribing and impact sales.

5. What are the prospects for expanding solriamfetol's indications?
Clinical trials for additional indications, such as shift work sleep disorder, are ongoing and may enhance long-term revenues.

---

Sources:

1. IQVIA. Global sleep disorder market analysis, 2022.
2. Novartis financial reports, 2022.
3. U.S. FDA drug approvals and patent data.
4. MarketWatch. Wakefulness agents market forecast, 2022.