Details for New Drug Application (NDA): 220152
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NDA 220152 describes NEREUS, which is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NEREUS profile page.
The generic ingredient in NEREUS is tradipitant. One supplier is listed for this compound. Additional details are available on the tradipitant profile page.
The generic ingredient in NEREUS is tradipitant. One supplier is listed for this compound. Additional details are available on the tradipitant profile page.
Summary for 220152
| Tradename: | NEREUS |
| Applicant: | Vanda Pharms Inc |
| Ingredient: | tradipitant |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220152
Generic Entry Date for 220152*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE;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: 220152
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEREUS | tradipitant | CAPSULE;ORAL | 220152 | NDA | Vanda Pharmaceuticals Inc. | 43068-585 | 43068-585-01 | 60 CARTON in 1 BOTTLE (43068-585-01) / 1 CAPSULE in 1 CARTON |
| NEREUS | tradipitant | CAPSULE;ORAL | 220152 | NDA | Vanda Pharmaceuticals Inc. | 43068-585 | 43068-585-02 | 36 CARTON in 1 BOTTLE (43068-585-02) / 1 CAPSULE in 1 CARTON |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 85MG | ||||
| Approval Date: | Dec 30, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 30, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 4, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF VOMITING INDUCED BY MOTION IN ADULTS BY ADMINISTERING TRADIPITANT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 4, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF VOMITING INDUCED BY MOTION IN ADULTS BY ADMINISTERING TRADIPITANT | ||||||||
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