Home / Generic availability / Plecanatide
When will generic Plecanatide be available?
Based on the patents and exclusivity the FDA lists today, generic plecanatide cannot be marketed in the United States before 2034-06-05, when the last listed protection expires.
Patents listed with the FDA
10 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 7041786 | 2028-01-30 | drug substance | TRULANCE |
| 9610321 | 2031-09-15 | method of use | TRULANCE |
| 9919024 | 2031-09-15 | method of use | TRULANCE |
| 9925231 | 2031-09-15 | drug product | TRULANCE |
| 11319346 | 2032-03-01 | drug product | TRULANCE |
| 9616097 | 2032-08-20 | drug product | TRULANCE |
| 10011637 | 2034-06-05 | drug substance | TRULANCE |
| 11142549 | 2034-06-05 | drug product | TRULANCE |
| 11834521 | 2034-06-05 | drug product | TRULANCE |
| 12146003 | 2034-06-05 | drug product | TRULANCE |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| TRULANCE | Brand (NDA) | SALIX PHARMACEUTICALS INC | 2017-01-19 | reference listed drug, reference standard |
What a generic Plecanatide would have to match
Forms and strengths
Tablets: 3 mg ( 3 ) TRULANCE Tablets: 3 mg: white to off-white, plain, round tablet debossed with “SP” on one side and “3” for 3 mg on the other side.
How it is supplied
TRULANCE tablets are packaged in a white, opaque, high-density polyethylene round bottle with a screw-top polypropylene child-resistant cap and heat-activated induction seal. Each bottle container-closure system also contains a desiccant and a polyester coil. TRULANCE 3 mg tablets are white to off-white, plain and round, debossed with “SP” on one side and “3” for 3 mg on the other side and supplied as: NDC Number Size 65649-003-30 Bottle of 30 Store at room temperature, 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep TRULANCE in a dry place. Protect from moisture. Keep TRULANCE in the original bottle. Do not remove...
Storage
Store at room temperature, 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep TRULANCE in a dry place. Protect from moisture. Keep TRULANCE in the original bottle. Do not remove desiccant from the bottle. Do not subdivide or repackage.
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 2024-04-04.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Glucagonprotection runs to March 2028
- Bivalirudinprotection runs to July 2028
- Degarelixprotection runs to February 2029
- Desmopressinprotection runs to May 2029
- Triptorelinprotection runs to June 2029
Frequently asked questions
When will generic Plecanatide be available?
Based on the patents and exclusivity the FDA lists today, generic plecanatide cannot be marketed in the United States before 2034-06-05, 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.
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