# LINZESS — FDA application NDA202811

Informational only - not investment advice.

Application NDA202811 · type NDA · FDA status: approved · original approval 2012-08-30

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | LINZESS | LINACLOTIDE | CAPSULE | ORAL | 145MCG | Prescription | not listed | Yes |
| 002 | LINZESS | LINACLOTIDE | CAPSULE | ORAL | 290MCG | Prescription | not listed | Yes |
| 003 | LINZESS | LINACLOTIDE | CAPSULE | ORAL | 72MCG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7304036, product 001; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 001; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 001; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 002; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 002; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 003; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 003; listed patent expiry date: 2026-08-30.
- Patent 7304036, product 001; listed patent expiry date: 2027-02-28.
- Patent 7304036, product 002; listed patent expiry date: 2027-02-28.
- Patent 7304036, product 003; listed patent expiry date: 2027-02-28.
- Patent 8933030, product 001; listed patent expiry date: 2031-02-17.
- Patent 8933030, product 002; listed patent expiry date: 2031-02-17.
- Patent 8933030, product 003; listed patent expiry date: 2031-02-17.
- Patent 8933030, product 003; listed patent expiry date: 2031-02-17.
- Patent 10675325, product 003; listed patent expiry date: 2031-08-11.
- Patent 10702576, product 003; listed patent expiry date: 2031-08-11.
- Patent 10702576, product 003; listed patent expiry date: 2031-08-11.
- Patent 8933030, product 001; listed patent expiry date: 2031-08-17.
- Patent 8933030, product 002; listed patent expiry date: 2031-08-17.
- Patent 8933030, product 003; listed patent expiry date: 2031-08-17.
- Patent 8748573, product 001; listed patent expiry date: 2031-10-30.
- Patent 8748573, product 001; listed patent expiry date: 2031-10-30.
- Patent 8748573, product 001; listed patent expiry date: 2031-10-30.
- Patent 8748573, product 002; listed patent expiry date: 2031-10-30.
- Patent 8748573, product 002; listed patent expiry date: 2031-10-30.
- Patent 8802628, product 001; listed patent expiry date: 2031-10-30.
- Patent 8802628, product 002; listed patent expiry date: 2031-10-30.
- Patent 10675325, product 003; listed patent expiry date: 2032-02-11.
- Patent 10702576, product 003; listed patent expiry date: 2032-02-11.
- Patent 8748573, product 001; listed patent expiry date: 2032-04-30.
- Patent 8748573, product 002; listed patent expiry date: 2032-04-30.
- Patent 8802628, product 001; listed patent expiry date: 2032-04-30.
- Patent 8802628, product 002; listed patent expiry date: 2032-04-30.
- Patent 9708371, product 001; listed patent expiry date: 2033-08-16.
- Patent 9708371, product 001; listed patent expiry date: 2033-08-16.
- Patent 9708371, product 001; listed patent expiry date: 2033-08-16.
- Patent 9708371, product 002; listed patent expiry date: 2033-08-16.
- Patent 9708371, product 003; listed patent expiry date: 2033-08-16.
- Patent 9708371, product 003; listed patent expiry date: 2033-08-16.
- Patent 9708371, product 001; listed patent expiry date: 2034-02-16.
- Patent 9708371, product 002; listed patent expiry date: 2034-02-16.
- Patent 9708371, product 003; listed patent expiry date: 2034-02-16.
- Exclusivity I-921, product 001; listed exclusivity date: 2026-06-12.
- Exclusivity I-921, product 003; listed exclusivity date: 2026-06-12.
- Exclusivity NPP, product 001; listed exclusivity date: 2028-11-04.
- Exclusivity PED, product 001; listed exclusivity date: 2029-05-04.
- Exclusivity NPP, product 003; listed exclusivity date: 2029-05-21.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- LINACLOTIDE · UNII N0TXR0XR5X · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202811. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.