Details for New Drug Application (NDA): 211230
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NDA 211230 describes SUNOSI, which is a drug marketed by Axsome Malta and is included in one NDA. It is available from one supplier. There are forty-two patents protecting this drug. Additional details are available on the SUNOSI profile page.
The generic ingredient in SUNOSI is solriamfetol hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the solriamfetol hydrochloride profile page.
The generic ingredient in SUNOSI is solriamfetol hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the solriamfetol hydrochloride profile page.
Summary for 211230
| Tradename: | SUNOSI |
| Applicant: | Axsome Malta |
| Ingredient: | solriamfetol hydrochloride |
| Patents: | 42 |
Pharmacology for NDA: 211230
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Suppliers and Packaging for NDA: 211230
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230 | NDA | Axsome Therapeutics, Inc. | 81968-350 | 81968-350-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01) |
| SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230 | NDA | Axsome Therapeutics, Inc. | 81968-350 | 81968-350-07 | 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jun 17, 2019 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 17, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 5, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 7, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) | ||||||||
Expired US Patents for NDA 211230
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-001 | Jun 17, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Axsome Malta | SUNOSI | solriamfetol hydrochloride | TABLET;ORAL | 211230-002 | Jun 17, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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