Generic competition · all medicines · read 12 November 2026
Is there a generic of Tadalafil, and who makes it?
Tadalafil appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 27 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 14.5 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Tadalafil appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 27 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came 14.5 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Adcirca and Cialis. 27 generic makers with 117 generic products listed as marketed; the first generic approval is dated 22 May 2018.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Inc | 22 May 2018 | 6 |
| Ajanta Pharma Ltd | 5 February 2019 | 5 |
| Aurobindo Pharma Ltd | 5 February 2019 | 5 |
| Chartwell Rx Sciences Llc | 5 February 2019 | 1 |
| Cipla Ltd | 5 February 2019 | 5 |
| Dr Reddys Laboratories Ltd | 5 February 2019 | 5 |
| Hetero Labs Ltd Unit Iii | 5 February 2019 | 5 |
| Accord Healthcare Inc | 26 March 2019 | 4 |
| Alembic Pharmaceuticals Ltd | 26 March 2019 | 4 |
| Amneal Pharmaceuticals Co Gmbh | 26 March 2019 | 4 |
| Lupin Ltd | 26 March 2019 | 4 |
| Qilu Pharmaceutical Hainan Co Ltd | 26 March 2019 | 4 |
15 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Chewable, Oral
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Tadliq. No generic is listed as marketed.
Patents and exclusivities still listed
- 24 December 2038Patent 11975006 drug product
- 24 December 2038Patent 12186322 drug product
- 24 December 2038Patent 11382917 drug product
- 24 December 2038Patent 11666576 drug product
- 24 December 2038Patent 12708626 drug product
- 24 December 2038Patent 12691120 drug product
- 24 December 2038Patent 12697338 drug product
- 24 December 2038Patent 12721849 drug product
1 more patents are listed.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.