PIRFENIDONE | N208780 | LEGACY PHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Genentech, Inc. et al v. Teva Pharmaceuticals USA, Inc. 15 patentsANDA 212759pirfenidone | D. Del. | 2019-01-24 | Terminated 2021-08-16 | — |
| D. Del. | 2019-01-22 | Terminated 2021-10-29 | — | |
| D. Del. | 2019-01-18 | Terminated 2021-10-15 | — | |
| D. Del. | 2019-01-18 | Terminated 2019-10-28 | — | |
| D. Del. | 2019-01-17 | Terminated 2020-01-02 | — | |
Genentech, Inc. et al v. Aurobindo Pharma Limited et al 16 patentsANDA 212596pirfenidone | D. Del. | 2019-01-17 | Terminated 2021-10-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Laurus Labs FDA-2018-P-1877 Laurus Labs Limited filed this citizen petition requesting that the FDA determine whether Genentech's ESBRIET (pirfenidone) 534 mg tablets, approved under NDA 208780, were discontinued for safety or efficacy reasons, and if not, that the agency accept ANDAs for all three strengths of pirfenidone tab | 505(q) | 2018-05-14 | Withdrawn | Laurus Labs |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7566729 | Apr 22, 2029 | — | — | — | — | |
| 7635707 | Apr 22, 2029 | — | — | — | — | |
| 7767700 | Dec 18, 2027 | — | — | — | — | |
| 7816383 | Jan 8, 2030 | — | — | — | — | |
| 7910610 | Jan 8, 2030 | — | — | — | — | |
| 8013002 | Jan 8, 2030 | — | — | — | — | |
| 8084475 | Jan 8, 2030 | — | — | — | — | |
| 8318780 | Jan 8, 2030 | — | — | — | — | |
| 8383150 | May 10, 2028 | — | — | Yes | — | |
| 8420674 | Dec 18, 2027 | — | — | — | — | |
| 8592462 | Apr 22, 2029 | — | — | — | — | |
| 8609701 | Apr 22, 2029 | — | — | — | — | |
| 8648098 | Jan 8, 2030 | — | — | — | — | |
| 8754109 | Jan 8, 2030 | — | — | — | — | |
| 8778947 | Aug 30, 2033 | — | — | — | — | |
| 10188637 | Mar 28, 2037 | — | — | Yes | — | — |