Details for New Drug Application (NDA): 202123
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NDA 202123 describes COMPLERA, 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 and one Paragraph IV challenge. Additional details are available on the COMPLERA profile page.
The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
Summary for 202123
| Tradename: | COMPLERA |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate |
| Patents: | 3 |
Suppliers and Packaging for NDA: 202123
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123 | NDA | Gilead Sciences, Inc. | 61958-1101 | 61958-1101-1 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;EQ 25MG BASE;300MG | ||||
| Approval Date: | Aug 10, 2011 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,857,102 | Patent Expiration: | Jan 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,125,879 | Patent Expiration: | Apr 21, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
| Patent: | 8,841,310 | Patent Expiration: | Dec 9, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
Expired US Patents for NDA 202123
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