FDA Orange Book · active-ingredient family
Tadalafil
Tadalafil is approved as 4 brand and 43 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CHEWTADZY · NDA 218527
4
Brand (NDA)
43
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHEWTADZYRLD×3 | B BETTER | NDA 218527 | — | Jun 28, 2024 | |
| TADLIQRLD | CMP DEV LLC | NDA 214522 | — | Jun 17, 2022 | |
| ADCIRCARLD | ELI LILLY CO | NDA 022332 | AB2 | May 22, 2009 | |
| CIALISRLD×4 | LILLY | NDA 021368 | — | Jan 07, 2008 |
Generic (ANDA) products (43)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TADALAFIL×4 | JUBILANT GENERICS | ANDA 210329 | AB1 | May 15, 2026 | |
| TADALAFIL×4 | SHANDONG | ANDA 216279 | AB1 | Dec 04, 2024 | |
| TADALAFIL×4 | FOURRTS LABS | ANDA 217606 | AB1 | Aug 13, 2024 | |
| TADALAFIL | ZYDUS PHARMS | ANDA 212515 | — | Jun 06, 2023 | |
| TADALAFIL×3 | NOVITIUM PHARMA | ANDA 215949 | AB1 | Mar 03, 2023 | |
| ALYQ | TEVA PHARMS INC | ANDA 216932 | AB2 | Oct 12, 2022 | |
| TADALAFIL×4 | PRINSTON INC | ANDA 210609 | AB1 | Aug 11, 2022 | |
| TADALAFIL | PRINSTON INC | ANDA 210608 | AB2 | Aug 11, 2022 | |
| TADALAFIL×4 | VKT PHARMA | ANDA 215556 | AB1 | Nov 04, 2021 | |
| TADALAFIL×4 | CHARTWELL RX | ANDA 210716 | — | Dec 29, 2020 | |
| TADALAFIL | SUNSHINE | ANDA 213496 | AB2 | Nov 23, 2020 | |
| TADALAFIL×4 | HANGZHOU BINJIANG | ANDA 208824 | AB1 | Oct 27, 2020 | |
| TADALAFIL×4 | UMEDICA | ANDA 211298 | AB1 | Oct 23, 2020 | |
| TADALAFIL | MACLEODS PHARMS LTD | ANDA 207290 | AB2 | Oct 16, 2019 | |
| TADALAFIL×4 | MACLEODS PHARMS LTD | ANDA 207244 | AB1 | Oct 07, 2019 | |
| TADALAFIL | NORVIUM BIOSCIENCE | ANDA 206957 | — | Apr 29, 2019 | |
| TADALAFIL×3 | RISING | ANDA 206956 | — | Apr 29, 2019 | |
| TADALAFIL×4 | WATSON LABS INC | ANDA 205885 | AB1 | Mar 29, 2019 | |
| TADALAFIL×4 | ACCORD HLTHCARE | ANDA 209167 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | AJANTA PHARMA LTD | ANDA 209654 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | ALEMBIC | ANDA 204809 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | AMNEAL PHARMS CO | ANDA 209744 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | AUROBINDO PHARMA LTD | ANDA 206285 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | CIPLA | ANDA 209539 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | DR REDDYS | ANDA 210069 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | HETERO LABS LTD III | ANDA 209908 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | LUPIN | ANDA 210567 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | QILU PHARM HAINAN | ANDA 210420 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | SUN PHARM | ANDA 208934 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | SUNSHINE | ANDA 211335 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | TORRENT | ANDA 211839 | AB1 | Mar 26, 2019 | |
| TADALAFIL×2 | TORRENT | ANDA 212062 | AB2 | Mar 26, 2019 | |
| TADALAFIL×4 | UNICHEM | ANDA 209250 | AB1 | Mar 26, 2019 | |
| TADALAFIL×4 | ZYDUS PHARMS | ANDA 206693 | AB1 | Mar 26, 2019 | |
| ALYQ | TEVA PHARMS USA | ANDA 209942 | AB2 | Feb 05, 2019 | |
| TADALAFIL | AJANTA PHARMA LTD | ANDA 210392 | AB2 | Feb 05, 2019 | |
| TADALAFIL | AUROBINDO PHARMA LTD | ANDA 206286 | AB2 | Feb 05, 2019 | |
| TADALAFIL | CHARTWELL RX | ANDA 210572 | AB2 | Feb 05, 2019 | |
| TADALAFIL | CIPLA | ANDA 210255 | AB2 | Feb 05, 2019 | |
| TADALAFIL | DR REDDYS | ANDA 210145 | AB2 | Feb 05, 2019 | |
| TADALAFIL | HETERO LABS LTD III | ANDA 209907 | AB2 | Feb 05, 2019 | |
| TADALAFIL | PHARMOBEDIENT | ANDA 200630 | — | Aug 03, 2018 | |
| TADALAFIL×4 | TEVA PHARMS USA | ANDA 090141 | AB1 | May 22, 2018 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11975006 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3397 |
| 12186322 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3397 |
| 11382917 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3397 |
| 11666576 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3397 |
Tadalafil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
