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 |
What a generic Octreotide would have to match
Forms and strengths
Injection: 100 mcg/mL or 500 mcg/mL of octreotide (as acetate) as a clear solution in a single-dose vial. Injection: 100 mcg/mL or 500 mcg/mL of octreotide (as acetate) in a single-dose vial. ( 3 )
How it is supplied
How Supplied Octreotide acetate injection is available in 1 mL single-dose vials as follows: NDC Package 68462-896-10 100 mcg/mL octreotide (as acetate)-Package of 10 vials 68462-896-01 100 mcg/mL octreotide (as acetate)- 1mL Single-Dose Vial 68462-897-10 500 mcg/mL octreotide (as acetate)-Package of 10 vials 68462-897-01 500 mcg/mL octreotide (as acetate)- 1mL Single-Dose Vial Storage and Handling For prolonged storage, octreotide acetate injection single-dose vials should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and store in outer carton in order to protect from light. At room temperature (20°C to 30°C or 70°F to 86°F), octreotide acetate injection is stable for 14...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-01-30.
Recalls involving Octreotide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc | NJ | Class II | 2026-04-24 | Lack of Assurance of Sterility: Quality system deficiencies identified |
| Teva Pharmaceuticals USA, Inc | NJ | Class II | 2026-03-17 | Lack of Assurance of Sterility: Quality system deficiencies identified |
| Viatris Inc | PA | Class I | 2022-10-07 | Presence of Particulate Matter: Product complaint for the presence of |
| Teva Pharmaceuticals USA | NJ | Class II | 2021-07-29 | Lack of Assurance of Sterility |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Terlipressinprotection runs to September 2027
- Abaloparatideprotection runs to October 2027
- Macimorelinprotection runs to October 2027
- Setmelanotideprotection runs to October 2027
- Plecanatideprotection runs to January 2028
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 2026-11-01. 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.
Related data
- Octreotide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book