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 · 9 docket documents 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 | Granted | Pilnova Pharma Inc. |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0935 · 3 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) requesting that the FDA declare Tadalafil Tablets, 40 mg suitable for submission as an ANDA, with ADCIRCA (Tadalafil Tablets, 20 mg, NDA 22-332) as the reference-listed drug, seeking approval for a | Other | 2012-09-18 | Withdrawn | — |
Citizens Petition from Public Citizen's Health Research Group FDA-2005-P-0192 · 5 docket documents Public Citizen filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA immediately add black box warnings to the three phosphodiesterase-5 inhibitors Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil), as well as to Revatio (sild | Other | 2005-10-20 | Denied | Public Citizen's Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$53.75
per ea
Lowest NADAC/Unit
$9.22
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00002446430CIALIS 20 MG TABLET | $53.75 | EA | Brand | $0.1721 | 2026-06-17 |
| 00002446330CIALIS 10 MG TABLET | $53.69 | EA | Brand | $0.1673 | 2026-03-18 |
| 00002446230CIALIS 5 MG TABLET | $9.22 | EA | Brand | $0.1031 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.