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Chemistry

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Also known as: Jzp-110 hydrochloride, 178429-65-7, Solriamfetol (hydrochloride), K7ro88sp7a, Solriamfetol hydrochloride [usan], Solriamfetol hydrochloride (usan)
Molecular Formula
C10H15ClN2O2
Molecular Weight
230.69  g/mol
InChI Key
KAOVAAHCFNYXNJ-SBSPUUFOSA-N
FDA UNII
K7RO88SP7A

Solriamfetol Hydrochloride
1 2D Structure

Solriamfetol Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R)-2-amino-3-phenylpropyl] carbamate;hydrochloride
2.1.2 InChI
InChI=1S/C10H14N2O2.ClH/c11-9(7-14-10(12)13)6-8-4-2-1-3-5-8;/h1-5,9H,6-7,11H2,(H2,12,13);1H/t9-;/m1./s1
2.1.3 InChI Key
KAOVAAHCFNYXNJ-SBSPUUFOSA-N
2.1.4 Canonical SMILES
C1=CC=C(C=C1)CC(COC(=O)N)N.Cl
2.1.5 Isomeric SMILES
C1=CC=C(C=C1)C[C@H](COC(=O)N)N.Cl
2.2 Other Identifiers
2.2.1 UNII
K7RO88SP7A
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2r)-2-amino-3-phenylpropyl Carbamate

2. (r)-2-amino-3-phenylpropylcarbamate Hydrochloride

3. Adx-n05

4. Benzenepropanol, Beta-amino-, Carbamate (ester), (betar)-

5. Jzp-110

6. Solriamfetol

7. Sunosi

2.3.2 Depositor-Supplied Synonyms

1. Jzp-110 Hydrochloride

2. 178429-65-7

3. Solriamfetol (hydrochloride)

4. K7ro88sp7a

5. Solriamfetol Hydrochloride [usan]

6. Solriamfetol Hydrochloride (usan)

7. R-228060

8. Sunosi (tn)

9. Unii-k7ro88sp7a

10. Adx-n05 Hydrochloride

11. Ykp-10a Hydrochloride

12. Schembl8430382

13. Adx-n-05 Hydrochloride

14. Skl-n-05 Hydrochloride

15. Chembl4297212

16. Dtxsid101027927

17. R-228060 Hydrochloride

18. Hy-109043a

19. Solriamfetol Hydrochloride [mi]

20. Solriamfetol Hydrochloride [who-dd]

21. Cs-0112102

22. O-carbamoyl-(d)-phenylalaninol Hydrochloride

23. D11328

24. Solriamfetol Hydrochloride [orange Book]

25. (d)-o-carbamoylphenylalaninol Hydrochloride Salt

26. R228060;jzp-110;adx-n05;skl-n05;ykp-10

27. (2r)-2-amino-3-phenylpropyl Carbamate, Monohydrochloride

28. (betar)-beta-amino-benzenepropanol 1-carbamate Hydrochloride (1:1)

29. (r)-(+)-2-amino-1-carbamoyloxy-3-phenylpropane Hydrochloride

30. Benzenepropanol, .beta.-amino-, 1-carbamate, Hydrochloride (1:1), (.beta.r)-

31. 561069-23-6

2.4 Create Date
2012-11-30
3 Chemical and Physical Properties
Molecular Weight 230.69 g/mol
Molecular Formula C10H15ClN2O2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass230.0822054 g/mol
Monoisotopic Mass230.0822054 g/mol
Topological Polar Surface Area78.3 Ų
Heavy Atom Count15
Formal Charge0
Complexity179
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy).

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).


5 Pharmacology and Biochemistry
5.1 ATC Code

N06BA14


USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2022-12-16

Pay. Date : 2022-11-14

DMF Number : 34741

Submission : 2020-03-31

Status : Active

Type : II

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Hetero Drugs Ltd

India

USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2023-05-16

Pay. Date : 2023-04-12

DMF Number : 38280

Submission : 2023-04-18

Status : Active

Type : II

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Hikma Pharmaceuticals Llc

United Kingdom

USDMF

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Hikma Pharmaceuticals Llc

United Kingdom
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GDUFA

DMF Review : Complete

Rev. Date : 2023-04-04

Pay. Date : 2022-12-19

DMF Number : 37548

Submission : 2022-12-28

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2023-03-16

Pay. Date : 2023-01-25

DMF Number : 36949

Submission : 2022-03-30

Status : Active

Type : II

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Listed Suppliers

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01

Inke S.A

Spain
  • fda
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  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

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Digital Content Digital Content

Solriamfetol Hydrochloride

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
Inke Company Banner

02

  • fda
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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Solriamfetol

About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...

Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
Egis Pharmaceuticals

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Solriamfetol Hydrochloride

About the Company : Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not on...

Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not only triggered us to become one of India’s largest generic and specialty pharmaceutical company but also, create a foothold in over 40 countries. 29% of our revenue is generated via offshore sales and it has consistently been ranked amongst the top ten pharmaceutical companies in India. They have 20 manufacturing facilities at multiple locations in India and the United States of America.
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Solriamfetol Hydrochloride

About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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Solriamfetol Hydrochloride

About the Company : Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in mark...

Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India. With 15 manufacturing facilities and 3 R&D centers dedicated to the goal of enriching lives across the globe.
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Drugs in Development

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Details:

Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for major depressive disorder (MDD) with and without severe excessive daytime sleepiness.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 01, 2025

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for major depressive disorder (MDD) with and without severe excessive daytime sleepiness.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

April 01, 2025

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Details:

Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for the treatment of attention deficit hyperactivity disorder.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 25, 2025

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for the treatment of attention deficit hyperactivity disorder.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 25, 2025

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Details:

Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 29, 2024

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

May 29, 2024

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Details:

Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of major depressive disorder.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 19, 2024

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04

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of major depressive disorder.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 19, 2024

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Details:

Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of binge eating disorder.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 04, 2024

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of binge eating disorder.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 04, 2024

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Details:

Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with Attention Deficit Hyperactivity Disorder (ADHD) in Adults.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 07, 2023

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with Attention Deficit Hyperactivity Disorder (ADHD) in Adults.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

July 07, 2023

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Details:

Under the agreement, Pharmanovia will be responsible for the development and marketing of Sunosi (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults with EDS due to narcolepsy or OSA, in Europe and MENA regions.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Pharmanovia

Deal Size: $167.0 million Upfront Cash: $66.0 million

Deal Type: Licensing Agreement February 22, 2023

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Under the agreement, Pharmanovia will be responsible for the development and marketing of Sunosi (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults with EDS due to narcolepsy or OSA, in Eur...

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : $66.0 million

February 22, 2023

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Details:

Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Axsome Therapeutics

Deal Size: Undisclosed Upfront Cash: $53.0 million

Deal Type: Divestment September 05, 2022

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AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : $53.0 million

September 05, 2022

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Details:

Sunosi (solriamfetol) is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Phase IVProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 09, 2022

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09

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol) is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

July 09, 2022

blank

Details:

Sunosi (solriamfetol) is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 28, 2022

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10

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Sunosi (solriamfetol) is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

June 28, 2022

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AXSOME MALTA

U.S.A
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AXSOME MALTA

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SOLRIAMFETOL HYDROCHLORIDE

Brand Name : SUNOSI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2019-06-17

Application Number : 211230

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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AXSOME MALTA

U.S.A
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AXSOME MALTA

U.S.A
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SOLRIAMFETOL HYDROCHLORIDE

Brand Name : SUNOSI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2019-06-17

Application Number : 211230

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 300MG

Approval Date :

Application Number : 218654

RX/OTC/DISCN :

RLD :

TE Code :

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 75MG

Approval Date :

Application Number : 218654

RX/OTC/DISCN :

RLD :

TE Code :

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 150MG

Approval Date :

Application Number : 218654

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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Solriamfetol hydrochloride

Brand Name : Sunosi

Dosage Form : Tablet, film-coated

Dosage Strength : 75 mg

Packaging : Blisterpakning 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Solriamfetol hydrochloride

Brand Name : Sunosi

Dosage Form : Tablet, film-coated

Dosage Strength : 150 mg

Packaging : Blisterpakning 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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NEWS #PharmaBuzz

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https://www.reuters.com/business/healthcare-pharmaceuticals/axsomes-depression-treatment-fails-meet-main-goal-late-stage-study-2025-04-01/

REUTERS
02 Apr 2025

https://www.fiercepharma.com/pharma/axsome-touts-success-phase-3-trial-sunosi-adhd

FIERCE PHARMA
26 Mar 2025

https://www.globenewswire.com/news-release/2025/03/05/3037271/33090/en/Axsome-Therapeutics-Settles-Sunosi-solriamfetol-Patent-Litigation-with-Hikma-Pharmaceuticals-USA.html

GLOBENEWSWIRE
05 Mar 2025

https://www.globenewswire.com/news-release/2024/09/24/2952012/33090/en/Axsome-Therapeutics-Presents-Data-from-Multiple-Programs-at-Sleep-Europe-2024.html

GLOBENEWSWIRE
24 Sep 2024

https://www.globenewswire.com/news-release/2024/08/21/2933398/33090/en/Axsome-Therapeutics-Reaches-Agreement-to-Dismiss-Sunosi-Solriamfetol-Patent-Litigation-with-Sandoz-Inc.html

GLOBENEWSWIRE
21 Aug 2024

https://www.globenewswire.com/news-release/2024/04/01/2855085/33090/en/Axsome-Therapeutics-Initiates-ENGAGE-Phase-3-Trial-of-Solriamfetol-for-the-Treatment-of-Binge-Eating-Disorder.html

GLOBENEWSWIRE
01 Apr 2024

Global Sales Information

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Regulatory FDF Prices

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Brand Name : Sunosi

United Kingdom
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Brand Name : Sunosi

United Kingdom
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Solriamfetol Hydrochloride

Dosage Form : Tablet, film-coated

Dosage Strength : 75 mg

Price Per Pack (Euro) : 191.06

Published in :

Country : Norway

RX/OTC/DISCN :

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Brand Name : Sunosi

United Kingdom
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Brand Name : Sunosi

United Kingdom
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Solriamfetol Hydrochloride

Dosage Form : Tablet, film-coated

Dosage Strength : 150 mg

Price Per Pack (Euro) : 263.56

Published in :

Country : Norway

RX/OTC/DISCN :

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Annual Reports

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Brand Name : Sunosi

Solriamfetol

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Brand Name : Sunosi

Ireland
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Solriamfetol

Main Therapeutic Indication : CNS & Anesthesia

Currency : USD

2020 Revenue in Millions : 28

2019 Revenue in Millions : 4

Growth (%) : 663

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Brand Name : Sunosi

Solriamfetol

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Brand Name : Sunosi

Ireland
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Solriamfetol

Main Therapeutic Indication : Sleep

Currency : USD

2021 Revenue in Millions : 58

2020 Revenue in Millions : 28

Growth (%) : 104

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Brand Name : Sunosi

Solriamfetol

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AAPS National Biotech
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Brand Name : Sunosi

Ireland
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Solriamfetol

Main Therapeutic Indication : Sleep

Currency : USD

2022 Revenue in Millions : 29

2021 Revenue in Millions : 58

Growth (%) : -50

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Brand Name : Sunosi

Solriamfetol

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Not Confirmed

Brand Name : Sunosi

Ireland
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AAPS National Biotech
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Solriamfetol

Main Therapeutic Indication : Sleep

Currency : USD

2023 Revenue in Millions : 0

2022 Revenue in Millions : 29

Growth (%) : Divested to Axsome

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Brand Name : Sunosi

Solriamfetol

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AAPS National Biotech
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Brand Name : Sunosi

Ireland
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AAPS National Biotech
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Solriamfetol

Main Therapeutic Indication : CNS & Anesthesia

Currency : USD

2019 Revenue in Millions : 4

2018 Revenue in Millions : 0

Growth (%) : New launch

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Market Place

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Patents & EXCLUSIVITIES

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US Patents

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01

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Arvo
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AXSOME MALTA

U.S.A
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Arvo
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SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 8440715

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-2548

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-06-11

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Arvo
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AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 12036194

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-3693

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-12-30

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AXSOME MALTA

U.S.A
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Arvo
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SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 12102609

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-3693

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-12-30

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AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 11771667

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-3693

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-12-30

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05

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Arvo
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AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 11872204

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-3693

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-12-30

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06

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Arvo
Not Confirmed

AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 11998639

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211230

Patent Use Code : U-2548

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-09-05

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07

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Arvo
Not Confirmed

AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 11850227

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-3775

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-03-19

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08

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Arvo
Not Confirmed

AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 11160779

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-3521

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-03-19

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09

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Arvo
Not Confirmed

AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 11865098

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-2548

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-06-01

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10

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Arvo
Not Confirmed

AXSOME MALTA

U.S.A
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Arvo
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

US Patent Number : 10351517

Drug Substance Claim :

Drug Product Claim :

Application Number : 211230

Patent Use Code : U-2548

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-06-07

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US Exclusivities

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AAPS National Biotech
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AXSOME MALTA

U.S.A
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AAPS National Biotech
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SOLRIAMFETOL HYDROCHLORIDE

Exclusivity Code : ODE-254

Exclusivity Expiration Date : 2026-06-17

Application Number : 211230

Product Number : 1

Exclusivity Details :

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AAPS National Biotech
Not Confirmed

AXSOME MALTA

U.S.A
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AAPS National Biotech
Not Confirmed

SOLRIAMFETOL HYDROCHLORIDE

Exclusivity Code : ODE-254

Exclusivity Expiration Date : 2026-06-17

Application Number : 211230

Product Number : 2

Exclusivity Details :

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ABOUT THIS PAGE

Looking for 178429-65-7 / Solriamfetol Hydrochloride API manufacturers, exporters & distributors?

Solriamfetol Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Solriamfetol Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Solriamfetol Hydrochloride manufacturer or Solriamfetol Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Solriamfetol Hydrochloride manufacturer or Solriamfetol Hydrochloride supplier.

PharmaCompass also assists you with knowing the Solriamfetol Hydrochloride API Price utilized in the formulation of products. Solriamfetol Hydrochloride API Price is not always fixed or binding as the Solriamfetol Hydrochloride Price is obtained through a variety of data sources. The Solriamfetol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Solriamfetol Hydrochloride

Synonyms

Jzp-110 hydrochloride, 178429-65-7, Solriamfetol (hydrochloride), K7ro88sp7a, Solriamfetol hydrochloride [usan], Solriamfetol hydrochloride (usan)

Cas Number

178429-65-7

Unique Ingredient Identifier (UNII)

K7RO88SP7A

JZP-110 hydrochloride Manufacturers

A JZP-110 hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JZP-110 hydrochloride, including repackagers and relabelers. The FDA regulates JZP-110 hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JZP-110 hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of JZP-110 hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

JZP-110 hydrochloride Suppliers

A JZP-110 hydrochloride supplier is an individual or a company that provides JZP-110 hydrochloride active pharmaceutical ingredient (API) or JZP-110 hydrochloride finished formulations upon request. The JZP-110 hydrochloride suppliers may include JZP-110 hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of JZP-110 hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

JZP-110 hydrochloride USDMF

A JZP-110 hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of JZP-110 hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of JZP-110 hydrochloride DMFs exist exist since differing nations have different regulations, such as JZP-110 hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A JZP-110 hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. JZP-110 hydrochloride USDMF includes data on JZP-110 hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The JZP-110 hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of JZP-110 hydrochloride suppliers with USDMF on PharmaCompass.

JZP-110 hydrochloride WC

A JZP-110 hydrochloride written confirmation (JZP-110 hydrochloride WC) is an official document issued by a regulatory agency to a JZP-110 hydrochloride manufacturer, verifying that the manufacturing facility of a JZP-110 hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting JZP-110 hydrochloride APIs or JZP-110 hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a JZP-110 hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of JZP-110 hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

JZP-110 hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing JZP-110 hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for JZP-110 hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture JZP-110 hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain JZP-110 hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a JZP-110 hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of JZP-110 hydrochloride suppliers with NDC on PharmaCompass.

JZP-110 hydrochloride GMP

JZP-110 hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of JZP-110 hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right JZP-110 hydrochloride GMP manufacturer or JZP-110 hydrochloride GMP API supplier for your needs.

JZP-110 hydrochloride CoA

A JZP-110 hydrochloride CoA (Certificate of Analysis) is a formal document that attests to JZP-110 hydrochloride's compliance with JZP-110 hydrochloride specifications and serves as a tool for batch-level quality control.

JZP-110 hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each JZP-110 hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

JZP-110 hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (JZP-110 hydrochloride EP), JZP-110 hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (JZP-110 hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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