Home / Generic availability / Cosyntropin
When will generic Cosyntropin be available?
The FDA lists no patents or exclusivity for cosyntropin, and 2 generic applications are already approved, so generic cosyntropin is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| CORTROSYN | Brand (NDA) | AMPHASTAR PHARMACEUTICALS INC | reference listed drug, reference standard | |
| COSYNTROPIN | Brand (NDA) | SANDOZ INC | 2008-02-21 | |
| COSYNTROPIN | Generic (ANDA) | PHARMOBEDIENT CONSULTING LLC | 2009-12-17 | |
| COSYNTROPIN | Generic (ANDA) | SANDOZ INC | 2012-06-29 |
What a generic Cosyntropin would have to match
Forms and strengths
For Injection: 0.25 mg of cosyntropin as a lyophilized powder in a single-dose vial for reconstitution. For injection: 0.25 mg of cosyntropin as a lyophilized powder in single-dose vial for reconstitution (3)
How it is supplied
How Supplied CORTROSYN (cosyntropin) for injection 0.25 mg, in a single-dose vial for reconstitution. Box contains 10 single-dose vials NDC 0548-5900-00 Storage and Handling Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CORTROSYN injection is intended as a single-dose injection and contains no antimicrobial preservative. Any unused portion should be discarded.
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 2025-01-30.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Enfuvirtideno patent or exclusivity listed
- Eptifibatideno patent or exclusivity listed
- Ganirelixno patent or exclusivity listed
- Goserelinno patent or exclusivity listed
- Icatibantno patent or exclusivity listed
Frequently asked questions
When will generic Cosyntropin be available?
The FDA lists no patents or exclusivity for cosyntropin, and 2 generic applications are already approved, so generic cosyntropin 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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