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. 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. 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211230
Generic Entry Date for 211230*:
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.
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: | 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: | 10,195,151 | Patent Expiration: | Sep 5, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,351,517 | 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) | ||||||||
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