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 |
|---|---|
| Axsome Therapeutics, Inc. | Phase 4 |
| University of Pennsylvania | 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 | 211230-001 | Jun 17, 2019 | RX | Yes | No | ⤷ 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 | ||||
| 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 | ⤷ 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 |
|---|---|---|---|
| Denmark | 3509582 | ⤷ Try a Trial | |
| Finland | 3509582 | ⤷ Try a Trial | |
| Japan | 2022003062 | （Ｒ）−２−アミノ−３−フェニルプロピルカルバメートの溶媒和物フォーム (SOLVATE FORM OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE) | ⤷ Try a Trial |
| 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for solriamfetol hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1890684 | CR 2020 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120 |
| 1890684 | 2020/012 | Ireland | ⤷ Try a Trial | PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1408 20200120 |
| 1890684 | SPC/GB20/017 | United Kingdom | ⤷ Try a Trial | 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 | 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 | 20C1014 | France | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
