Home / Generic availability / Linaclotide
When will generic Linaclotide be available?
Based on the patents and exclusivity the FDA lists today, generic linaclotide cannot be marketed in the United States before 2034-02-16, when the last listed protection expires.
Patents listed with the FDA
14 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 7304036 | 2026-08-30 | drug substance, drug product | LINZESS |
| 7304036*PED | 2027-02-28 | method of use | LINZESS |
| 8933030 | 2031-02-17 | drug product | LINZESS |
| 10675325 | 2031-08-11 | drug product | LINZESS |
| 10702576 | 2031-08-11 | method of use | LINZESS |
| 8933030*PED | 2031-08-17 | method of use | LINZESS |
| 8748573 | 2031-10-30 | method of use | LINZESS |
| 8802628 | 2031-10-30 | drug product | LINZESS |
| 10675325*PED | 2032-02-11 | method of use | LINZESS |
| 10702576*PED | 2032-02-11 | method of use | LINZESS |
| 8748573*PED | 2032-04-30 | method of use | LINZESS |
| 8802628*PED | 2032-04-30 | method of use | LINZESS |
| 9708371 | 2033-08-16 | drug product | LINZESS |
| 9708371*PED | 2034-02-16 | method of use | LINZESS |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| I-921 | 2026-06-12 | New indication (3 years) | LINZESS |
| NPP | 2028-11-04 | New patient population | LINZESS |
| PED | 2029-05-04 | Pediatric exclusivity (adds 6 months) | LINZESS |
| NPP | 2029-05-21 | New patient population | LINZESS |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| LINZESS | Brand (NDA) | ABBVIE INC | 2012-08-30 | reference listed drug, reference standard |
| LINACLOTIDE | Generic (ANDA) | MYLAN PHARMACEUTICALS INC | 2021-02-09 | |
| LINACLOTIDE | Generic (ANDA) | AUROBINDO PHARMA LTD | 2023-02-07 | |
| LINACLOTIDE | Generic (ANDA) | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 2026-09-24 |
Recalls involving Linaclotide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Cardinal Health Inc. | OH | Class II | 2021-03-15 | CGMP Deviations: Intermittent exposure to temperature excursion during |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Semaglutideprotection runs to March 2027
- Lanreotideprotection runs to March 2027
- Tirzepatideprotection runs to May 2027
- Octreotideprotection runs to June 2027
- Terlipressinprotection runs to September 2027
Frequently asked questions
When will generic Linaclotide be available?
Based on the patents and exclusivity the FDA lists today, generic linaclotide cannot be marketed in the United States before 2034-02-16, 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
- Linaclotide clinical trials →Registered studies, phases and status
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- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book