Details for New Drug Application (NDA): 210455
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NDA 210455 describes SYMTUZA, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the SYMTUZA profile page.
The generic ingredient in SYMTUZA is cobicistat; darunavir; 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; darunavir; emtricitabine; tenofovir alafenamide fumarate profile page.
The generic ingredient in SYMTUZA is cobicistat; darunavir; 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; darunavir; emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 210455
| Tradename: | SYMTUZA |
| Applicant: | Janssen Prods |
| Ingredient: | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210455
Generic Entry Date for 210455*:
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: 210455
Suppliers and Packaging for NDA: 210455
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455 | NDA | Janssen Products LP | 59676-800 | 59676-800-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30) |
| SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455 | NDA | Janssen Products LP | 59676-800 | 59676-800-99 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;800MG;200MG;EQ 10MG BASE | ||||
| Approval Date: | Jul 17, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 6, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 19, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH = 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 17, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 210455
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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