LINZESS — FDA application NDA202811
Listed sponsor: ABBVIE · ABBV company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 7304036 | 001 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-1278 |
| Patent 7304036 | 001 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-4345 |
| Patent 7304036 | 001 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-1516 |
| Patent 7304036 | 002 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-1278 |
| Patent 7304036 | 002 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-1516 |
| Patent 7304036 | 003 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-1516 |
| Patent 7304036 | 003 | listed patent expiry date: 2026-08-30 | drug substance, drug product, U-3644 |
| Patent 7304036 | 001 | listed patent expiry date: 2027-02-28 | pediatric extension |
| Patent 7304036 | 002 | listed patent expiry date: 2027-02-28 | pediatric extension |
| Patent 7304036 | 003 | listed patent expiry date: 2027-02-28 | pediatric extension |
| Patent 8933030 | 001 | listed patent expiry date: 2031-02-17 | drug product, U-4345 |
| Patent 8933030 | 002 | listed patent expiry date: 2031-02-17 | drug product |
| Patent 8933030 | 003 | listed patent expiry date: 2031-02-17 | drug product, U-1516 |
| Patent 8933030 | 003 | listed patent expiry date: 2031-02-17 | drug product, U-3644 |
| Patent 10675325 | 003 | listed patent expiry date: 2031-08-11 | drug product |
| Patent 10702576 | 003 | listed patent expiry date: 2031-08-11 | U-1516 |
| Patent 10702576 | 003 | listed patent expiry date: 2031-08-11 | U-3644 |
| Patent 8933030 | 001 | listed patent expiry date: 2031-08-17 | pediatric extension |
| Patent 8933030 | 002 | listed patent expiry date: 2031-08-17 | pediatric extension |
| Patent 8933030 | 003 | listed patent expiry date: 2031-08-17 | pediatric extension |
| Patent 8748573 | 001 | listed patent expiry date: 2031-10-30 | U-1515 |
| Patent 8748573 | 001 | listed patent expiry date: 2031-10-30 | U-1516 |
| Patent 8748573 | 001 | listed patent expiry date: 2031-10-30 | U-4345 |
| Patent 8748573 | 002 | listed patent expiry date: 2031-10-30 | U-1516 |
| Patent 8748573 | 002 | listed patent expiry date: 2031-10-30 | U-1515 |
| Patent 8802628 | 001 | listed patent expiry date: 2031-10-30 | drug product |
| Patent 8802628 | 002 | listed patent expiry date: 2031-10-30 | drug product |
| Patent 10675325 | 003 | listed patent expiry date: 2032-02-11 | pediatric extension |
| Patent 10702576 | 003 | listed patent expiry date: 2032-02-11 | pediatric extension |
| Patent 8748573 | 001 | listed patent expiry date: 2032-04-30 | pediatric extension |
| Patent 8748573 | 002 | listed patent expiry date: 2032-04-30 | pediatric extension |
| Patent 8802628 | 001 | listed patent expiry date: 2032-04-30 | pediatric extension |
| Patent 8802628 | 002 | listed patent expiry date: 2032-04-30 | pediatric extension |
| Patent 9708371 | 001 | listed patent expiry date: 2033-08-16 | drug product, U-1515 |
| Patent 9708371 | 001 | listed patent expiry date: 2033-08-16 | drug product, U-1516 |
| Patent 9708371 | 001 | listed patent expiry date: 2033-08-16 | drug product, U-4345 |
| Patent 9708371 | 002 | listed patent expiry date: 2033-08-16 | drug product, U-1515 |
| Patent 9708371 | 003 | listed patent expiry date: 2033-08-16 | drug product, U-1516 |
| Patent 9708371 | 003 | listed patent expiry date: 2033-08-16 | drug product, U-3644 |
| Patent 9708371 | 001 | listed patent expiry date: 2034-02-16 | pediatric extension |
| Patent 9708371 | 002 | listed patent expiry date: 2034-02-16 | pediatric extension |
| Patent 9708371 | 003 | listed patent expiry date: 2034-02-16 | pediatric extension |
| Exclusivity I-921 | 001 | listed exclusivity date: 2026-06-12 | FDA code as listed |
| Exclusivity I-921 | 003 | listed exclusivity date: 2026-06-12 | FDA code as listed |
| Exclusivity NPP | 001 | listed exclusivity date: 2028-11-04 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2029-05-04 | FDA code as listed |
| Exclusivity NPP | 003 | listed exclusivity date: 2029-05-21 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.