Details for New Drug Application (NDA): 021937
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NDA 021937 describes ATRIPLA, which is a drug marketed by Gilead Sciences and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ATRIPLA profile page.
The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021937
| Tradename: | ATRIPLA |
| Applicant: | Gilead Sciences |
| Ingredient: | efavirenz; emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 3 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG;200MG;300MG | ||||
| Approval Date: | Jul 12, 2006 | TE: | RLD: | Yes | |||||
| Patent: | 8,598,185 | Patent Expiration: | Apr 28, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,018,192 | Patent Expiration: | Jun 13, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HIV-1 INFECTION IN ADULTS | ||||||||
| Patent: | 9,018,192 | Patent Expiration: | Jun 13, 2026 | Product Flag? | 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 021937
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | 6,043,230*PED | ⤷ Get Started Free |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | 7,402,588*PED | ⤷ Get Started Free |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | 6,642,245*PED | ⤷ Get Started Free |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | 5,814,639*PED | ⤷ Get Started Free |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | 5,977,089*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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