Details for New Drug Application (NDA): 202022
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NDA 202022 describes EDURANT, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the EDURANT profile page.
The generic ingredient in EDURANT 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 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 202022
| Tradename: | EDURANT |
| Applicant: | Janssen Prods |
| Ingredient: | rilpivirine hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202022
Generic Entry Date for 202022*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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: 202022
| Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202022
Suppliers and Packaging for NDA: 202022
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022 | NDA | Janssen Products, LP | 59676-278 | 59676-278-01 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-278-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | May 20, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Sep 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 202022
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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