Details for New Drug Application (NDA): 208215
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NDA 208215 describes DESCOVY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DESCOVY profile page.
The generic ingredient in DESCOVY is emtricitabine; 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; tenofovir alafenamide fumarate profile page.
The generic ingredient in DESCOVY is emtricitabine; 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; tenofovir alafenamide fumarate profile page.
Summary for 208215
| Tradename: | DESCOVY |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | emtricitabine; tenofovir alafenamide fumarate |
| Patents: | 3 |
Pharmacology for NDA: 208215
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 208215
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215 | NDA | Gilead Sciences, Inc. | 61958-2002 | 61958-2002-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1) |
| DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215 | NDA | Gilead Sciences, Inc. | 61958-2002 | 61958-2002-2 | 30 TABLET in 1 BLISTER PACK (61958-2002-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;EQ 25MG BASE | ||||
| Approval Date: | Apr 4, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 28, 2024 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG | ||||||||
| Regulatory Exclusivity Expiration: | Sep 28, 2024 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG | ||||||||
| Patent: | 7,390,791*PED | Patent Expiration: | Oct 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 208215
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | 7,803,788 | ⤷ Subscribe |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | 5,814,639*PED | ⤷ Subscribe |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | 6,703,396*PED | ⤷ Subscribe |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | 6,642,245*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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