Details for New Drug Application (NDA): 207561
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NDA 207561 describes GENVOYA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the GENVOYA profile page.
The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.
The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 207561
| Tradename: | GENVOYA |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207561
Generic Entry Date for 207561*:
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: 207561
Suppliers and Packaging for NDA: 207561
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561 | NDA | Gilead Sciences, Inc. | 61958-1901 | 61958-1901-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;150MG;200MG;EQ 10MG BASE | ||||
| Approval Date: | Nov 5, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,039,718*PED | Patent Expiration: | Apr 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 7,176,220*PED | Patent Expiration: | Feb 27, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 7,390,791*PED | Patent Expiration: | Oct 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 207561
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | 5,814,639*PED | ⤷ Subscribe |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | 7,803,788 | ⤷ Subscribe |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | 7,800,788 | ⤷ Subscribe |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | 6,703,396*PED | ⤷ Subscribe |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | 5,914,331*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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