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 one branded drug marketed by Axsome Malta and is included in one NDA. There are thirty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Solriamfetol hydrochloride has seventy patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for SOLRIAMFETOL HYDROCHLORIDE

International Patents:	70
US Patents:	36
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	12
Patent Applications:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOLRIAMFETOL HYDROCHLORIDE
DailyMed Link:	SOLRIAMFETOL HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOLRIAMFETOL HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

10,195,151

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

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

See all SOLRIAMFETOL HYDROCHLORIDE clinical trials

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	211230-001	Jun 17, 2019		RX	Yes	No	11,160,779
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	11,969,404
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	10,912,754
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,560,354		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,986,455

International Patents for SOLRIAMFETOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Philippines	12019502723	METHODS AND COMPOSITIONS FOR TREATING EXCESSIVE SLEEPINESS
World Intellectual Property Organization (WIPO)	2009112459
Japan	2011514906
Australia	2018278332	Methods and compositions for treating excessive sleepiness
Japan	2019533640	（Ｒ）−２−アミノ−３−フェニルプロピルカルバメートの製剤

Supplementary Protection Certificates for SOLRIAMFETOL HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	20C1014	France		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
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

SOLRIAMFETOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Solriamfetol Hydrochloride (Sunosi)

Introduction

Solriamfetol hydrochloride, marketed as Sunosi, is a dual-acting dopamine and norepinephrine reuptake inhibitor designed to treat excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnea (OSA). Here, we delve into the market dynamics and financial trajectory of this medication.

Clinical Efficacy and Market Authorization

Sunosi's market authorization was based on substantial evidence from two pivotal Phase III clinical trials, Study 14-002 and Study 14-003, which demonstrated its efficacy in reducing EDS in patients with narcolepsy and OSA[3][4].

Mechanism of Action

Solriamfetol works by inhibiting the reuptake of dopamine and norepinephrine in the brain, although its precise mechanism of action is not fully characterized. This unique mechanism has garnered positive feedback from patients and healthcare professionals[3][4].

Market Performance

In 2021, Sunosi net sales reached $57.9 million, representing a year-over-year growth of 104%. This significant growth underscores the drug's market potential and acceptance[2].

Acquisition and Ownership

In March 2022, Axsome Therapeutics acquired Sunosi from Jazz Pharmaceuticals, marking a strategic move to expand Axsome's presence in the neuroscience market. The acquisition included worldwide commercial, development, manufacturing, and intellectual property rights, except for certain Asian markets[2][5].

Financial Terms of the Acquisition

The transaction involved an upfront payment of $53 million to Jazz, along with high single-digit royalties on Axsome's U.S. net sales of Sunosi in its current indication and mid single-digit royalties on future indications. Axsome also assumed commitments to SK Biopharmaceuticals and Aerial Biopharma, including single-digit tiered royalties and potential revenue and development milestones[2][5].

Growth Potential

Sunosi is anticipated to contribute significantly to Axsome's revenue, with peak revenue potential estimated to exceed $1 billion. This projection is based on further growth in the current indications and potential development in new indications. The drug's patent expiries extend out to 2040, with possible extensions, providing a long-term revenue stream[2].

Synergy with Axsome’s Portfolio

Sunosi aligns well with Axsome’s therapeutic focus, particularly with its anticipated commercialization of AXS-05 for depression and AXS-07 for migraine. These conditions often overlap with EDS, allowing for synergistic marketing and prescriber engagement through Axsome’s Digital Centric Commercialization™ (DCC) platform[2].

Commercial Strategy

Axsome’s DCC platform is designed to optimize physician targeting and engagement, enhancing the reach to key prescriber groups. This platform, combined with the therapeutic overlap, is expected to accelerate Sunosi’s commercial success and ensure uninterrupted patient access during the transition period[2].

Safety and Regulatory Profile

Sunosi has an acceptable safety profile when used as described in the approved Product Monograph. However, it requires dosage adjustments for patients with moderate or severe renal impairment due to its prolonged half-life in these populations. Appropriate warnings, precautions, and monitoring recommendations are in place to manage identified safety concerns[3][4].

Patient and Physician Feedback

Sunosi has received consistent positive feedback from patients, healthcare professionals, and providers. This positive reception is a strong indicator of its clinical and commercial potential[2].

Future Indications

There is potential for rapid development of Sunosi in new indications, further expanding its market reach. Axsome’s track record in clinical development provides a promising foundation for exploring these additional uses[2].

Financial Impact on Axsome

The acquisition of Sunosi is expected to be immediately revenue-generating for Axsome, with the potential to be breakeven to Axsome’s operating plan in 2023 and substantially accretive thereafter. This financial trajectory positions Axsome for significant growth as a premier biopharmaceutical company focused on CNS conditions[2].

Key Takeaways

• Clinical Efficacy: Sunosi has demonstrated clinically meaningful efficacy in treating EDS associated with narcolepsy and OSA.
• Market Performance: Significant year-over-year growth in net sales.
• Acquisition: Axsome Therapeutics acquired Sunosi from Jazz Pharmaceuticals, enhancing Axome's neuroscience portfolio.
• Financial Terms: Included an upfront payment and royalties.
• Growth Potential: Estimated peak revenue potential exceeds $1 billion.
• Synergy: Aligns well with Axsome’s existing therapeutic focus and commercial platform.
• Safety Profile: Acceptable safety profile with necessary dosage adjustments for renal impairment.
• Future Indications: Potential for development in new indications.

FAQs

What is Sunosi used for?

Sunosi (solriamfetol hydrochloride) is used to treat excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnea (OSA)[3][4].

Who acquired Sunosi from Jazz Pharmaceuticals?

Axsome Therapeutics acquired Sunosi from Jazz Pharmaceuticals in March 2022[2][5].

What is the financial potential of Sunosi?

Sunosi is estimated to have a peak revenue potential of over $1 billion, driven by growth in current and potential new indications[2].

How does Sunosi work?

Sunosi works by inhibiting the reuptake of dopamine and norepinephrine in the brain, though its precise mechanism is not fully characterized[3][4].

Are there any safety concerns with Sunosi?

Yes, Sunosi requires dosage adjustments for patients with moderate or severe renal impairment due to its prolonged half-life in these populations. Appropriate warnings and precautions are in place to manage identified safety concerns[3][4].

What is the role of Axsome’s Digital Centric Commercialization™ (DCC) platform in promoting Sunosi?

Axsome’s DCC platform is designed to optimize physician targeting and engagement, enhancing the reach to key prescriber groups and accelerating Sunosi’s commercial success[2].

Sources

1. European Medicines Agency - Sunosi, INN-solriamfetol hydrochloride - European Medicines Agency[1].
2. GlobeNewswire - Axsome Therapeutics to Acquire Sunosi® from Jazz - GlobeNewswire[2].
3. Health Canada - Summary Basis of Decision for Sunosi[3].
4. FDA - 211230Orig1s000 211230Orig2s000 - accessdata.fda.gov[4].
5. Jazz Pharmaceuticals - Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics[5].