Details for New Drug Application (NDA): 021976
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NDA 021976 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the PREZISTA profile page.
The generic ingredient in PREZISTA is darunavir. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.
The generic ingredient in PREZISTA is darunavir. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.
Summary for 021976
| Tradename: | PREZISTA |
| Applicant: | Janssen Prods |
| Ingredient: | darunavir |
| Patents: | 1 |
Pharmacology for NDA: 021976
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors |
Suppliers and Packaging for NDA: 021976
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREZISTA | darunavir | TABLET;ORAL | 021976 | NDA | Janssen Products LP | 59676-562 | 59676-562-01 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01) |
| PREZISTA | darunavir | TABLET;ORAL | 021976 | NDA | Janssen Products LP | 59676-563 | 59676-563-01 | 480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 23, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Feb 25, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 21, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021976
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | PREZISTA | darunavir | TABLET;ORAL | 021976-001 | Jun 23, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Janssen Prods | PREZISTA | darunavir | TABLET;ORAL | 021976-001 | Jun 23, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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