Details for Patent: 11,986,455
Which drugs does patent 11,986,455 protect, and when does it expire?
Patent 11,986,455 protects SUNOSI and is included in one NDA.
Summary for Patent: 11,986,455
| Title: | Methods of providing solriamfetol therapy to subjects with impaired renal function |
| Abstract: | The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment. |
| Inventor(s): | Katayoun Zomorodi |
| Assignee: | Axsome Malta Ltd |
| Application Number: | US18/295,146 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 11,986,455 |
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Patent Claim Types: see list of patent claims | Use; |
Drugs Protected by US Patent 11,986,455
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-001 | Jun 17, 2019 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT | ⤷ Start Trial | |||
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
