Details for New Drug Application (NDA): 021752
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NDA 021752 describes TRUVADA, which is a drug marketed by Gilead and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRUVADA profile page.
The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021752
| Tradename: | TRUVADA |
| Applicant: | Gilead |
| Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 4 |
Pharmacology for NDA: 021752
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021752
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752 | NDA | Gilead Sciences, Inc | 61958-0701 | 61958-0701-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1) |
| TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752 | NDA | Gilead Sciences, Inc | 61958-0703 | 61958-0703-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0703-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG;300MG | ||||
| Approval Date: | Aug 2, 2004 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,592,397 | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1 | ||||||||
| Patent: | 8,592,397 | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HIV | ||||||||
| Patent: | 8,592,397 | Patent Expiration: | Jan 13, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
Expired US Patents for NDA 021752
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | 6,703,396*PED | ⤷ Subscribe |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | 5,914,331*PED | ⤷ Subscribe |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | 5,814,639*PED | ⤷ Subscribe |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | 6,703,396*PED | ⤷ Subscribe |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | 9,457,036 | ⤷ Subscribe |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | 6,043,230*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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