Solriamfetol - Generic Drug Details
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Summary for solriamfetol
International Patents: | 30 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 1 |
Patent Applications: | 41 |
What excipients (inactive ingredients) are in solriamfetol? | solriamfetol excipients list |
DailyMed Link: | solriamfetol at DailyMed |
Recent Clinical Trials for solriamfetol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Charles Andrew Czeisler, MD, PhD | Phase 4 |
Massachusetts General Hospital | Phase 2/Phase 3 |
Rochester Center for Behavioral Medicine | Phase 4 |
Generic filers with tentative approvals for SOLRIAMFETOL
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 150MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 75MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for solriamfetol
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-001 | Jun 17, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |