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When will generic Oxytocin be available?
The FDA lists no patents or exclusivity for oxytocin, and 3 generic applications are already approved, so generic oxytocin is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| SYNTOCINON | Brand (NDA) | RETROPHIN INC | ||
| OXYTOCIN | Brand (NDA) | HIKMA PHARMACEUTICALS USA INC | 2007-01-10 | reference listed drug, reference standard |
| SYNTOCINON | Brand (NDA) | NOVARTIS PHARMACEUTICALS CORP | ||
| OXYTOCIN | Brand (NDA) | FRESENIUS KABI USA LLC | 2007-07-27 | reference listed drug, reference standard |
| PITOCIN | Brand (NDA) | PH HEALTH LTD | 2007-07-27 | reference listed drug, reference standard |
| OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5%, OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | Brand (NDA) | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | 1985-03-29 | reference listed drug |
| OXYTOCIN | Generic (ANDA) | DR REDDYS LABORATORIES LTD | 2008-01-24 | |
| OXYTOCIN | Generic (ANDA) | SAGENT PHARMACEUTICALS INC | 2018-07-13 | |
| OXYTOCIN | Generic (ANDA) | HIKMA FARMACEUTICA PORTUGAL SA | 2013-02-13 |
Frequently asked questions
When will generic Oxytocin be available?
The FDA lists no patents or exclusivity for oxytocin, and 3 generic applications are already approved, so generic oxytocin 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.