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 |
What a generic Calcitonin would have to match
Forms and strengths
Calcitonin salmon injection, USP, synthetic is available as a clear, colorless, sterile solution of synthetic calcitonin salmon, USP in individual 2 mL multiple-dose vials containing 200 USP Units per mL. Injection: 200 USP Units per mL sterile solution in 2 mL multiple-dose vials ( 3 )
How it is supplied
How Supplied Calcitonin salmon injection, USP, synthetic is available as a clear, colorless, sterile solution in individual 2 mL multiple-dose vials containing 200 USP Units per mL. NDC 70710-1875-1 carton containing 1 x 2 mL multiple-dose vial Storage and Handling Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.
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 2026-03-06.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Cetrorelixno patent or exclusivity listed
- Cosyntropinno patent or exclusivity listed
- Enfuvirtideno patent or exclusivity listed
- Eptifibatideno patent or exclusivity listed
- Ganirelixno patent or exclusivity listed
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 2026-11-01. 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.
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