Details for New Drug Application (NDA): 219016
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NDA 219016 describes EDURANT PED, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the EDURANT PED profile page.
The generic ingredient in EDURANT PED is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
The generic ingredient in EDURANT PED is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
Summary for 219016
| Tradename: | EDURANT PED |
| Applicant: | Janssen Prods |
| Ingredient: | rilpivirine hydrochloride |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219016
Generic Entry Date for 219016*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;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: 219016
| Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 219016
Suppliers and Packaging for NDA: 219016
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016 | NDA | Janssen Products, LP | 59676-280 | 59676-280-90 | 9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Mar 15, 2024 | TE: | RLD: | Yes | |||||
| Patent: | 11,065,198 | Patent Expiration: | Oct 23, 2037 | 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: | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE PATIENTS 2 YEARS OF AGE AND OLDER, WEIGHING AT LEAST 14KG, WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY | ||||||||
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