Home / Generic availability / Octreotide
When will generic Octreotide be available?
Based on the patents and exclusivity the FDA lists today, generic octreotide cannot be marketed in the United States before 2041-12-29, when the last listed protection expires.
Patents listed with the FDA
21 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 11969471 | 2029-09-17 | drug product | MYCAPSSA |
| 11986529 | 2029-09-17 | method of use | MYCAPSSA |
| 8329198 | 2029-09-17 | drug product | MYCAPSSA |
| 8535695 | 2029-09-17 | method of use | MYCAPSSA |
| 9265812 | 2029-09-17 | drug product | MYCAPSSA |
| 9566246 | 2029-09-17 | drug product | MYCAPSSA |
| 10238709 | 2036-02-03 | method of use | MYCAPSSA |
| 10695397 | 2036-02-03 | method of use | MYCAPSSA |
| 11052126 | 2036-02-03 | method of use | MYCAPSSA |
| 11338011 | 2036-02-03 | method of use | MYCAPSSA |
| 11510963 | 2036-02-03 | method of use | MYCAPSSA |
| 11857595 | 2036-02-03 | method of use | MYCAPSSA |
| 12246054 | 2036-02-03 | method of use | MYCAPSSA |
| 12251418 | 2036-02-03 | method of use | MYCAPSSA |
| 10342850 | 2038-05-15 | drug product | BYNFEZIA PEN |
| 11052196 | 2040-11-03 | method of use | BYNFEZIA PEN |
| 11246991 | 2040-11-03 | method of use | BYNFEZIA PEN |
| 11534553 | 2040-11-03 | method of use | BYNFEZIA PEN |
| 11141457 | 2040-12-28 | method of use | MYCAPSSA |
| 11890316 | 2040-12-28 | method of use | MYCAPSSA |
| 12350475 | 2041-12-29 | method of use | BYNFEZIA PEN |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| CGT | 2026-07-27 | Competitive generic therapy (180 days) | OCTREOTIDE ACETATE |
| CGT | 2026-08-02 | Competitive generic therapy (180 days) | OCTREOTIDE ACETATE |
| ODE-474 | 2027-06-26 | Orphan drug exclusivity (7 years) | MYCAPSSA |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| SANDOSTATIN | Brand (NDA) | NOVARTIS PHARMACEUTICALS CORP | 1988-10-21 | reference listed drug, reference standard |
| SANDOSTATIN LAR | Brand (NDA) | NOVARTIS PHARMACEUTICALS CORP | 1998-11-25 | reference listed drug, reference standard |
| OCTREOTIDE ACETATE | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 2005-10-03 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 2005-11-21 | |
| OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Generic (ANDA) | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 2005-03-28 | reference standard |
| OCTREOTIDE ACETATE | Generic (ANDA) | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 2005-04-08 | reference standard |
| OCTREOTIDE ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2008-03-04 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2008-03-04 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2008-03-04 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2007-08-14 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2007-08-14 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | FRESENIUS KABI USA LLC | 2006-02-10 | |
| OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Generic (ANDA) | FRESENIUS KABI USA LLC | 2006-02-10 | |
| OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Generic (ANDA) | MYLAN INSTITUTIONAL LLC | 2011-02-10 | |
| OCTREOTIDE ACETATE (PRESERVATIVE FREE) | Generic (ANDA) | SAGENT PHARMACEUTICALS INC | 2013-11-12 | |
| OCTREOTIDE ACETATE PRESERVATIVE FREE | Generic (ANDA) | WOCKHARDT USA INC | 2011-05-11 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | WOCKHARDT USA INC | 2011-05-11 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | SAGENT PHARMACEUTICALS INC | 2013-11-12 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 2018-09-07 | |
| OCTREOTIDE ACETATE | Generic (ANDA) | HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 2018-12-27 | |
| MYCAPSSA | Brand (NDA) | CHIESI FARMACEUTICI SPA | 2020-06-26 | reference listed drug, reference standard |
| OCTREOTIDE ACETATE | Generic (ANDA) | TEVA PHARMACEUTICALS USA INC | 2023-12-05 | |
| BYNFEZIA PEN | Brand (NDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2024-09-27 | reference listed drug, reference standard |
| OCTREOTIDE ACETATE | Generic (ANDA) | MYLAN LABORATORIES LTD | 2025-12-12 |
Frequently asked questions
When will generic Octreotide be available?
Based on the patents and exclusivity the FDA lists today, generic octreotide cannot be marketed in the United States before 2041-12-29, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.