DARUNAVIR | N021976 | JANSSEN PRODUCTS LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
JANSSEN PRODUCTS, L.P. et al v. AMNEAL PHARMACEUTICALS, LLC et al 3 patentsANDA 212493darunavir | D.N.J. | 2018-12-26 | Terminated 2019-05-02 | — |
JANSSEN PRODUCTS, L.P. et al v. DR. REDDY'S LABORATORIES, INC. et al 3 patentsANDA 21-1578darunavir | D.N.J. | 2018-05-24 | Terminated 2019-05-09 | — |
JANSSEN PRODUCTS, L.P. et al v. AUROBINDO PHARMA LTD. et al 4 patentsANDA 210677darunavir | D.N.J. | 2017-09-07 | Terminated 2018-01-16 | — |
| D.N.J. | 2014-08-13 | Terminated 2018-08-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-1379 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether PREZISTA (darunavir) Tablets, 400 mg, approved under NDA 21-976, was voluntarily withdrawn from sale for safety or effectiveness reasons. The petitioner seeks th | 505(q) | 2013-11-27 | Granted | — |
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0756 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition on October 14, 2011, requesting that the FDA determine whether Tibotec's PREZISTA (Darunavir) Tablets, 300 mg (NDA 021976) was voluntarily withdrawn from marketing for safety or effectiveness reasons, and if not, that ANDAs for this product be | 505(q) | 2011-11-02 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$70.17
per ea
Lowest NADAC/Unit
$34.98
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59676056630PREZISTA 800 MG TABLET | $70.17 | EA | Brand | $2.27 | 2026-06-17 |
| 59676056201PREZISTA 600 MG TABLET | $34.98 | EA | Brand | $1.18 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7700645 | Dec 26, 2026PED: Jun 26, 2027 | PED | Yes | Yes | — | — |