DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205677
NDA 205677 describes HETLIOZ, which is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the HETLIOZ profile page.
The generic ingredient in HETLIOZ is tasimelteon. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tasimelteon profile page.
The generic ingredient in HETLIOZ is tasimelteon. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tasimelteon profile page.
Summary for 205677
| Tradename: | HETLIOZ |
| Applicant: | Vanda Pharms Inc |
| Ingredient: | tasimelteon |
| Patents: | 7 |
Pharmacology for NDA: 205677
| Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 205677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677 | NDA | Vanda Pharmaceuticals Inc. | 43068-220 | N | 43068-220-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Jan 31, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 31, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 31, 2021 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Dec 9, 2018 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON | ||||||||
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