Home / Generic availability / Pasireotide
When will generic Pasireotide be available?
Based on the patents and exclusivity the FDA lists today, generic pasireotide cannot be marketed in the United States before 2028-05-23, when the last listed protection expires.
Patents listed with the FDA
4 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 7759308 | 2026-10-25 | drug product | SIGNIFOR LAR KIT |
| 7473761 | 2026-12-14 | drug substance, drug product | SIGNIFOR LAR KIT |
| 7473761 | 2026-12-14 | drug substance, drug product | SIGNIFOR |
| 9351923 | 2028-05-23 | drug product | SIGNIFOR LAR KIT |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| SIGNIFOR | Brand (NDA) | RECORDATI RARE DISEASES INC | 2012-12-14 | reference listed drug, reference standard |
| SIGNIFOR LAR KIT | Brand (NDA) | RECORDATI RARE DISEASES INC | 2014-12-15 | reference listed drug, reference standard |
What a generic Pasireotide would have to match
Forms and strengths
Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose, 1 mL colorless glass ampule. Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose ampule ( 3 )
How it is supplied
SIGNIFOR is supplied as a single dose, colorless glass ampule packaged in a box of 60 ampules, arranged in 10 packs of 6 ampules each. The following packaging configurations are available. 0.3 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules NDC# 55292-131-60 0.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules NDC# 55292-132-60 0.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules NDC# 55292-133-60 Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F), 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 2026-02-17.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Leuprolideprotection runs to January 2027
- Carfilzomibprotection runs to January 2027
- Exenatideprotection runs to February 2027
- Linaclotideprotection runs to February 2027
- Semaglutideprotection runs to March 2027
Frequently asked questions
When will generic Pasireotide be available?
Based on the patents and exclusivity the FDA lists today, generic pasireotide cannot be marketed in the United States before 2028-05-23, when the last listed protection expires.
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
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