Solriamfetol hydrochloride - Generic Drug Details
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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 twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Solriamfetol hydrochloride has sixty-five patent family members in twenty-two countries.
One supplier is listed for this compound.
Summary for solriamfetol hydrochloride
International Patents: | 65 |
US Patents: | 27 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 10 |
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
Generic Entry Date for solriamfetol hydrochloride*:
Constraining patent/regulatory exclusivity:
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 |
---|---|
University of Pennsylvania | Phase 4 |
Axsome Therapeutics, Inc. | Phase 4 |
Charles Andrew Czeisler, MD, PhD | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for solriamfetol hydrochloride
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 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-001 | Jun 17, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-001 | Jun 17, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for solriamfetol hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2611713 | TRAITEMENT DE TROUBLES DU CYCLE SOMMEIL-EVEIL (TREATMENT OF SLEEP-WAKE DISORDERS) | ⤷ Try a Trial |
Malaysia | 197631 | FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE | ⤷ Try a Trial |
Japan | 5024635 | ⤷ Try a Trial | |
Japan | 7148498 | ⤷ Try a Trial | |
South Korea | 102513800 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for solriamfetol hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1890684 | 2090011-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120 |
1890684 | C202030015 | Spain | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PREFERIBLEMENTE UNA SAL DE CLORHIDRATO DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1408; DATE OF AUTHORISATION: 20200116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1408; DATE OF FIRST AUTHORISATION IN EEA: 20200116 |
1890684 | 14/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, VORZUGSWEISE EIN HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1408 (MITTEILUNG) 20200120 |
1890684 | 132020000000040 | Italy | ⤷ Try a Trial | 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 | C01890684/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOLUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68177 22.03.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |