Home / Generic availability / Ziconotide
When will generic Ziconotide be available?
The FDA lists no patents or exclusivity for ziconotide, and 0 generic applications are already approved, so generic ziconotide is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| PRIALT | Brand (NDA) | ESTEVE PHARMACEUTICALS SA | 2004-12-28 | reference listed drug, reference standard |
What a generic Ziconotide would have to match
Forms and strengths
PRIALT (ziconotide) solution, intrathecal infusion is supplied as a 25 mcg/mL concentration in single-use 20 mL glass vials and as a 100 mcg/mL concentration in single-use glass vials containing 1 mL or 5 mL of solution. Intrathecal solution ( 3 ): 25 mcg/mL 100 mcg/mL
How it is supplied
16.1 How Supplied PRIALT is supplied as a 25 mcg/mL solution in a single-use 20 mL glass vial and as a 100 mcg/mL solution in single-use glass vials containing 1 mL or 5 mL of solution. One vial is packaged per carton. Presentation (NDC) 25 mcg/mL: 20 mL vial (70720-723-10). Only the undiluted 25 mcg/mL formulation should be used for PRIALT naïve pump priming. 100 mcg/mL: 1 mL vial (70720-720-10) 5 mL vial (70720-722-10) 16.2 Storage Refrigerate PRIALT during transit. Store PRIALT at 2°C to 8°C (36°F to 46°F). PRIALT, once diluted aseptically with saline, may be stored at 2°C to 8°C for 24 hours. Do NOT freeze PRIALT. Protect from light.
Storage
16.2 Storage Refrigerate PRIALT during transit. Store PRIALT at 2°C to 8°C (36°F to 46°F). PRIALT, once diluted aseptically with saline, may be stored at 2°C to 8°C for 24 hours. Do NOT freeze PRIALT. Protect from light.
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 2025-05-31.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Romidepsinprotection runs to December 2026
- Pasireotideprotection runs to December 2026
- Leuprolideprotection runs to January 2027
- Carfilzomibprotection runs to January 2027
- Exenatideprotection runs to February 2027
Frequently asked questions
When will generic Ziconotide be available?
The FDA lists no patents or exclusivity for ziconotide, and 0 generic applications are already approved, so generic ziconotide 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.
Related data
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book