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Details for New Drug Application (NDA): 205677
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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 eleven 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: | 11 |
Generic Entry Opportunity Date for 205677
Generic Entry Date for 205677*:
Constraining patent/regulatory exclusivity:
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.
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 | 43068-220-01 | 30 CAPSULE in 1 BOTTLE (43068-220-01) |
Paragraph IV (Patent) Challenges for 205677
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HETLIOZ | CAPSULE;ORAL | tasimelteon | 205677 | 2018-01-31 |
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, 2021 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 12, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Jan 25, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS | ||||||||
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