Home / Generic availability / Calcitonin
When will generic Calcitonin be available?
The FDA lists no patents or exclusivity for calcitonin, and 11 generic applications are already approved, so generic calcitonin is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| CALCIMAR | Brand (NDA) | SANOFI AVENTIS US LLC | ||
| CALCIMAR | Brand (NDA) | SANOFI AVENTIS US LLC | reference listed drug | |
| MIACALCIN | Brand (NDA) | MYLAN IRELAND LTD | 1986-07-03 | reference listed drug, reference standard |
| CIBACALCIN | Brand (NDA) | NOVARTIS PHARMACEUTICALS CORP | 1986-10-31 | |
| MIACALCIN | Brand (NDA) | SAPTALIS PHARMACEUTICALS LLC | 1995-08-17 | reference listed drug |
| FORTICAL | Brand (NDA) | UPSHER SMITH LABORATORIES LLC | 2005-08-12 | |
| CALCITONIN-SALMON | Generic (ANDA) | IGI LABORATORIES INC | 1995-04-14 | |
| CALCITONIN-SALMON | Generic (ANDA) | APOTEX INC | 2008-11-17 | reference standard |
| CALCITONIN-SALMON | Generic (ANDA) | PH HEALTH LTD | 2009-06-08 | |
| CALCITONIN-SALMON | Generic (ANDA) | PH HEALTH LTD | 2021-11-10 | |
| CALCITONIN-SALMON | Generic (ANDA) | CUSTOPHARM INC | 2021-05-14 | |
| CALCITONIN-SALMON | Generic (ANDA) | FRESENIUS KABI USA LLC | 2024-12-05 | |
| CALCITONIN-SALMON | Generic (ANDA) | CIPLA LTD | 2024-09-20 | |
| CALCITONIN-SALMON | Generic (ANDA) | DR REDDYS LABORATORIES LTD | 2024-04-11 | |
| CALCITONIN-SALMON | Generic (ANDA) | ZYDUS PHARMACEUTICALS USA INC | 2026-03-04 | |
| CALCITONIN-SALMON | Generic (ANDA) | AMNEAL EU LTD | 2025-09-26 | |
| CALCITONIN-SALMON | Generic (ANDA) | SAGENT PHARMACEUTICALS | 2025-07-09 |
Frequently asked questions
When will generic Calcitonin be available?
The FDA lists no patents or exclusivity for calcitonin, and 11 generic applications are already approved, so generic calcitonin is available in the United States.
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.