Generic competition · all medicines · read 12 November 2026
Is there a generic of Simvastatin, and who makes it?
Simvastatin appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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.
- Simvastatin appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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: Zocor. 10 generic makers with 49 generic products listed as marketed; the first generic approval is dated 23 June 2006.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Aurobindo Pharma Ltd | 20 December 2006 | 5 |
| Biocon Pharma Ltd | 20 December 2006 | 5 |
| Rising Pharma Holdings Inc | 20 December 2006 | 5 |
| Zydus Pharmaceuticals Usa Inc | 20 December 2006 | 5 |
| Lupin Ltd | 11 May 2007 | 5 |
| Accord Healthcare Inc | 26 February 2008 | 5 |
| Tp Anda Holdings Llc | 30 August 2010 | 5 |
| Hetero Labs Ltd Unit Iii | 25 November 2014 | 5 |
| Invagen Pharmaceuticals Inc | 13 November 2017 | 5 |
| Pharmobedient Consulting Llc | 27 November 2024 | 4 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Orally Disintegrating, 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: Flolipid. No generic is listed as marketed.
Patents and exclusivities still listed
- 26 April 2027Patent 10300041 drug product
- 23 February 2030Patent 9597289 drug product
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.