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 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for solriamfetol |
| 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 |
|---|---|
| Johns Hopkins University | Phase 2 |
| National Multiple Sclerosis Society | Phase 2 |
| Axsome Therapeutics, Inc. | Phase 2 |
Generic filers with tentative approvals for SOLRIAMFETOL
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try for Free | ⤷ Try for Free | 75MG | TABLET |
| ⤷ Try for Free | ⤷ Try for Free | 300MG | TABLET |
| ⤷ Try for Free | ⤷ Try for Free | 150MG | TABLET |
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 | 8,877,806 | ⤷ Try for Free | ⤷ Try for Free | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | 12,090,126 | ⤷ Try for Free | ⤷ Try for Free | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | 11,753,368 | ⤷ Try for Free | ⤷ Try for Free | ||||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | RX | Yes | Yes | 12,036,194 | ⤷ Try for Free | ⤷ Try for Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
