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When will generic Vasopressin be available?
Based on the patents and exclusivity the FDA lists today, generic vasopressin cannot be marketed in the United States before 2044-09-27, when the last listed protection expires. 1 generic application already holds tentative FDA approval, meaning the FDA has judged it acceptable and it is waiting on these dates.
Generics already cleared and waiting
A tentative approval means the FDA has already judged the generic to meet its standards but cannot allow marketing yet.
- AMNEAL EU LTD tentative approval 2022, application ANDA212945
Patents listed with the FDA
16 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10010575 | 2035-01-30 | method of use | VASOSTRICT |
| 12186362 | 2035-01-30 | drug product | VASOSTRICT |
| 9919026 | 2035-01-30 | drug product | VASOSTRICT |
| 9925233 | 2035-01-30 | method of use | VASOSTRICT |
| 9925234 | 2035-01-30 | method of use | VASOSTRICT |
| 9962422 | 2035-01-30 | method of use | VASOSTRICT |
| 9968649 | 2035-01-30 | method of use | VASOSTRICT |
| 9974827 | 2035-01-30 | method of use | VASOSTRICT |
| 9981006 | 2035-01-30 | method of use | VASOSTRICT |
| 9375478 | 2035-01-30 | method of use | VASOSTRICT |
| 9687526 | 2035-01-30 | method of use | VASOSTRICT |
| 9744209 | 2035-01-30 | method of use | VASOSTRICT |
| 9744239 | 2035-01-30 | method of use | VASOSTRICT |
| 9750785 | 2035-01-30 | drug product | VASOSTRICT |
| 9937223 | 2035-01-30 | method of use | VASOSTRICT |
| 12447190 | 2044-09-27 | drug product | VASOPRESSIN IN SODIUM CHLORIDE 0.9% |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| PITRESSIN TANNATE | Brand (NDA) | PARKE DAVIS DIV WARNER LAMBERT CO | reference listed drug | |
| VASOSTRICT | Brand (NDA) | PH HEALTH LTD | 2014-04-17 | reference listed drug, reference standard |
| VASOPRESSIN | Generic (ANDA) | EAGLE PHARMACEUTICALS INC | 2021-12-15 | |
| VASOPRESSIN | Generic (ANDA) | AMPHASTAR PHARMACEUTICALS INC | 2022-07-18 | |
| VASOPRESSIN | Generic (ANDA) | SANDOZ INC | 2026-05-06 | |
| VASOPRESSIN | Generic (ANDA) | SANDOZ INC | 2026-05-06 | |
| VASOPRESSIN | Brand (NDA) | AMERICAN REGENT INC | 2020-08-03 | reference listed drug, reference standard |
| VASOPRESSIN | Generic (ANDA) | AMNEAL EU LTD | 2022-08-05 | |
| VASOPRESSIN | Generic (ANDA) | FRESENIUS KABI USA LLC | 2023-05-26 | |
| VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5% | Generic (ANDA) | DR REDDYS LABORATORIES LTD | 2024-05-08 | |
| VASOPRESSIN | Generic (ANDA) | EUGIA PHARMA SPECIALITIES LTD | 2022-08-15 | |
| VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5% | Generic (ANDA) | GLAND PHARMA LTD | 2024-02-09 | |
| VASOPRESSIN IN SODIUM CHLORIDE 0.9% | Brand (NDA) | BAXTER HEALTHCARE CORP | 2023-09-29 | reference listed drug, reference standard |
| VASOPRESSIN IN SODIUM CHLORIDE 0.9% | Brand (NDA) | LONG GROVE PHARMACEUTICALS LLC | 2024-07-11 | reference listed drug, reference standard |
| VASOPRESSIN | Generic (ANDA) | CIPLA LTD | 2023-12-06 |
Frequently asked questions
When will generic Vasopressin be available?
Based on the patents and exclusivity the FDA lists today, generic vasopressin cannot be marketed in the United States before 2044-09-27, when the last listed protection expires. 1 generic application already holds tentative FDA approval, meaning the FDA has judged it acceptable and it is waiting on these dates.
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.