Generic competition · all medicines · read 12 November 2026
Is there a generic of Octreotide Acetate, and who makes it?
Octreotide Acetate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 9 generic makers listed as marketed across them. 2 groups have 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 16.4 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.
- Octreotide Acetate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 9 generic makers listed as marketed across them.
- 2 groups have 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 16.4 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.
Injectable, Injection
Four or more generic makers listed
Brand listed as marketed: Sandostatin and Sandostatin Lar. 9 generic makers with 38 generic products listed as marketed; the first generic approval is dated 28 March 2005.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| West-Ward Pharmaceuticals International Ltd | 28 March 2005 | 5 |
| Meitheal Pharmaceuticals Inc | 3 October 2005 | 5 |
| Fresenius Kabi Usa Llc | 10 February 2006 | 5 |
| Mylan Institutional Llc | 10 February 2011 | 3 |
| Sagent Pharmaceuticals Inc | 12 November 2013 | 5 |
| Heritage Pharmaceuticals Inc Dba Avet Pharmaceuticals Inc | 7 September 2018 | 5 |
| Gland Pharma Ltd | 13 June 2023 | 4 |
| Teva Pharmaceuticals Usa Inc | 5 December 2023 | 3 |
| Mylan Laboratories Ltd | 12 December 2025 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Delayed Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Mycapssa. No generic is listed as marketed.
Patents and exclusivities still listed
- 26 June 2027Exclusivity ODE-474 Mycapssa
- 17 September 2029Patent 8535695
- 17 September 2029Patent 11986529
- 17 September 2029Patent 11969471 drug product
- 17 September 2029Patent 8329198 drug product
- 17 September 2029Patent 9265812 drug product
- 17 September 2029Patent 9566246 drug product
- 3 February 2036Patent 11338011
- 3 February 2036Patent 12251418
8 more patents are listed.
Solution, Subcutaneous
Brand listed, no generic listed as marketed
Brand listed as marketed: Bynfezia Pen. No generic is listed as marketed.
Patents and exclusivities still listed
- 15 May 2038Patent 10342850 drug product
- 3 November 2040Patent 11246991
- 3 November 2040Patent 11534553
- 3 November 2040Patent 11052196
- 29 December 2041Patent 12350475
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.