Details for New Drug Application (NDA): 208351
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NDA 208351 describes ODEFSEY, which is a drug marketed by Gilead Sciences 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 ODEFSEY profile page.
The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.
The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.
Summary for 208351
| Tradename: | ODEFSEY |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208351
Generic Entry Date for 208351*:
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.
Pharmacology for NDA: 208351
Suppliers and Packaging for NDA: 208351
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351 | NDA | Gilead Sciences, Inc. | 61958-2101 | 61958-2101-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;EQ 25MG BASE;EQ 25MG BASE | ||||
| Approval Date: | Mar 1, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 7,125,879 | Patent Expiration: | Apr 21, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
| Patent: | 7,390,791*PED | Patent Expiration: | Oct 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,754,065*PED | Patent Expiration: | Feb 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 208351
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