TADALAFIL | N021368 | ELI LILLY AND CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ELI LILLY AND COMPANY et al v. UMEDICA LABORATORIES PVT., LTD. 1 patentANDA 211298tadalafil | D.N.J. | 2018-08-02 | Terminated 2019-02-14 | — |
ELI LILLY AND COMPANY et al v. TORRENT PHARMACEUTICALS LIMITED et al 1 patentANDA 211839tadalafil | D.N.J. | 2018-07-11 | Terminated 2018-10-09 | — |
| D.N.J. | 2018-05-10 | Terminated 2018-11-15 | — | |
ELI LILLY AND COMPANY et al v. SUNSHINE LAKE PHARMA CO., LTD. et al 1 patentANDA 211335tadalafil | D.N.J. | 2018-04-09 | Terminated 2018-08-16 | — |
| D. Del. | 2018-01-04 | Terminated 2018-05-24 | — | |
ELI LILLY AND COMPANY et al v. UNICHEM LABORATORIES LIMITED et al 1 patentANDA 209250tadalafil | D.N.J. | 2017-12-19 | Terminated 2018-05-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pilnova Pharma Inc. FDA-2025-P-1656 Pilnova Pharma Inc. submitted this suitability petition pursuant to section 505(j)(2)(C) requesting FDA approval to file an Abbreviated New Drug Application for Tadalafil Orally Disintegrating Strips in strengths of 2.5 mg, 5.0 mg, 10 mg, and 20 mg, with CIALIS Tadalafil Tablets under NDA 021368 as | Suitability | 2025-06-12 | Open | Pilnova Pharma Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.