Product profile · United States
LINZESS
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Exact-product FDA Final ANDA approval and AB/RLD mapping verified; Authorized Generic and Tentative Approval excluded.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US7371727 | 2024-01-28 | DS — | N | N | PROCESS Claims 1-5 require chemical synthesis and purification; claim 6 is product-by-process. The manufacturing limitations prevent unrestricted molecule or DS-equivalent classification. | — | — | — |
| US7704947 | 2024-01-28 | DS/DP — | Y | N | TRUE_DS Claim 1 peptide genus includes the linaclotide sequence CCEYCCNPACTGCY; the variable aromatic position includes Tyr. No formulation or indication restriction. | — | — | — |
| US7745409 | 2024-01-28 | DS/DP — | Y | N | TRUE_DS Claim 1 uses comprising for the 13-residue CCEYCCNPACTGC core; it encompasses linaclotide with its additional terminal Tyr. Narrower dependent consisting claims are not the basis for this classification. | — | — | — |
| US8080526 | 2024-01-28 | DS/DP — | Y | N | TRUE_DS Claim 1 encompasses the peptide sequence, and claim 2 specifies linaclotide CCEYCCNPACTGCY with the three disulfide linkages. Unrestricted substance coverage. | — | — | — |
| US8110553 | 2024-01-28 | — — | N | Y | DS_EQUIVALENT Independent claims 1 and 3 use comprising for the linaclotide core and address motility/GI treatment; claims 5-8 include constipation and chronic/idiopathic constipation. They encompass adult CIC and pediatric FC without a population or regimen carve-out. Not a substance claim. | — | — | — |
| 7304036 | 2026-08-30 | DS/DP/U U-4566 | Y | N | TRUE_DS | — | — | — |
| 7304036 | 2026-08-30 | DS/DP/U U-3644 | Y | N | TRUE_DS | — | — | — |
| 7304036 | 2026-08-30 | DS/DP/U U-1516 | Y | N | TRUE_DS | — | — | — |
| 7304036 | 2027-02-28 | — — | Y | N | TRUE_DS | — | 2027-02-28 | — |
| 7304036 | 2027-02-28 | DS/DP/U/PED U-1516,U-3644,U-4566 | Y | N | TRUE_DS Claims 1-6 cover the linaclotide peptide sequence and acceptable salts. TRUE_DS. | — | 2027-02-28 | — |
| 8933030 | 2031-02-17 | DP/U U-1516 | N | N | DP | — | — | — |
| 8933030 | 2031-02-17 | DP/U U-4566 | N | N | DP | — | — | — |
| 8933030 | 2031-02-17 | DP/U U-3644 | N | N | DP | — | — | — |
| 10675325 | 2031-08-11 | DP — | N | N | DP | — | — | — |
| 10702576 | 2031-08-11 | U U-4566 | N | N | U | — | — | — |
| 10702576 | 2031-08-11 | U U-3644 | N | N | U | — | — | — |
| 10702576 | 2031-08-11 | U U-1516 | N | N | U | — | — | — |
| 8933030 | 2031-08-17 | — — | N | N | DP | — | 2031-08-17 | — |
| 8933030 | 2031-08-17 | DP/U/PED U-1516,U-3644,U-4566 | N | N | DP Claims identify modified/degradation peptides and compositions containing those peptides with linaclotide. These are not the broad active-peptide TRUE_DS claim. | — | 2031-08-17 | — |
| 10675325 | 2032-02-11 | — — | N | N | DP | — | 2032-02-11 | — |
| 10675325 | 2032-02-11 | DP/PED — | N | N | DP Claims require linaclotide, calcium and histidine in defined molar ratios. Stabilized formulation DP. | — | 2032-02-11 | — |
| 10702576 | 2032-02-11 | — — | N | N | U | — | 2032-02-11 | — |
| 10702576 | 2032-02-11 | U/PED U-1516,U-3644,U-4566 | N | N | U Treatment/formulation claims depend on a stable linaclotide formulation. No promotion from broad indication wording without unavoidable composition coverage. | — | 2032-02-11 | — |
| 9708371 | 2033-08-16 | DP/U U-3644 | N | N | DP | — | — | — |
| 9708371 | 2033-08-16 | DP/U U-4566 | N | N | DP | — | — | — |
| 9708371 | 2033-08-16 | DP/U U-1516 | N | N | DP | — | — | — |
| 9708371 | 2034-02-16 | — — | N | N | DP | — | 2034-02-16 | — |
| 9708371 | 2034-02-16 | DP/U/PED U-1516,U-3644,U-4566 | N | N | DP Claims identify modified peptides and linaclotide compositions containing limited proportions of those peptides. DP, not broad active-peptide TRUE_DS. | — | 2034-02-16 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2012-08-30 | 2017-08-30 | Active-moiety-wide regulatory exclusivity. NUMBRINO shares the cocaine NCE barrier originating with GOPRELTO; its listed NCE end is not a fresh five-year term from its 2020 approval. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2017-08-30 | Source | |
| NS | 2017-01-25 | 2020-01-25 | 72 mcg strength for adult CIC. Full approved scope at the 2017 strength approval; not a barrier for the pediatric FC indication added in 2023/2026. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2020-01-25 | Source | |
| I-921 | 2023-06-12 | 2026-06-12 | Functional constipation in pediatric patients aged 6-17 years. Adult CIC remains outside this right; the 72 mcg product has both uses. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| I-921 | 2023-06-12 | 2026-06-12 | Functional constipation in pediatric patients aged 6-17 years. Adult CIC remains outside this right; the 72 mcg product has both uses. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| NPP | 2026-05-21 | 2029-05-21 | Expansion of pediatric FC use to ages 2-5 years under S-023. Adult CIC and established older-pediatric use are outside this new-population right. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| NPP | 2026-05-21 | 2029-05-21 | Expansion of pediatric FC use to ages 2-5 years under S-023. Adult CIC and established older-pediatric use are outside this new-population right. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source |
2026-10-12 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 211255 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ACTAVIS LABS FL | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211255 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ACTAVIS LABS FL | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211255 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | — | ACTAVIS LABS FL | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211255 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | — | ACTAVIS LABS FL | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 2 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 211255 / 001 | ACTAVIS LABS FL | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211255 / 001 | ACTAVIS LABS FL | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (16)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2026-09-24 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA211255/001 -> NDA202811/003 | Source |
| PATENT | 2024-01-28 | LISTING_CONTEXT | Claim 1 encompasses the peptide sequence, and claim 2 specifies linaclotide CCEYCCNPACTGCY with the three disulfide linkages. Unrestricted substance coverage. | Source |
| PATENT | 2024-01-28 | LISTING_CONTEXT | Claim 1 uses comprising for the 13-residue CCEYCCNPACTGC core; it encompasses linaclotide with its additional terminal Tyr. Narrower dependent consisting claims are not the basis for this classification. | Source |
| PATENT | 2024-01-28 | LISTING_CONTEXT | Claim 1 peptide genus includes the linaclotide sequence CCEYCCNPACTGCY; the variable aromatic position includes Tyr. No formulation or indication restriction. | Source |
| PATENT | 2024-01-28 | LISTING_CONTEXT | Claims 1-5 require chemical synthesis and purification; claim 6 is product-by-process. The manufacturing limitations prevent unrestricted molecule or DS-equivalent classification. | Source |
| PATENT | 2024-01-28 | LISTING_CONTEXT | Independent claims 1 and 3 use comprising for the linaclotide core and address motility/GI treatment; claims 5-8 include constipation and chronic/idiopathic constipation. They encompass adult CIC and pediatric FC without a population or regimen carve-out. Not a substance claim. | Source |
| PATENT | 2027-02-28 | CANONICAL_ANCHOR | Claims 1-6 cover the linaclotide peptide sequence and acceptable salts. TRUE_DS. | Source |
| PATENT | 2031-08-17 | FTO_TAIL | Claims identify modified/degradation peptides and compositions containing those peptides with linaclotide. These are not the broad active-peptide TRUE_DS claim. | Source |
| PATENT | 2032-02-11 | FTO_TAIL | Claims require linaclotide, calcium and histidine in defined molar ratios. Stabilized formulation DP. | Source |
| PATENT | 2032-02-11 | FTO_TAIL | Treatment/formulation claims depend on a stable linaclotide formulation. No promotion from broad indication wording without unavoidable composition coverage. | Source |
| PATENT | 2034-02-16 | FTO_TAIL | Claims identify modified peptides and linaclotide compositions containing limited proportions of those peptides. DP, not broad active-peptide TRUE_DS. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Expansion of pediatric FC use to ages 2-5 years under S-023. Adult CIC and established older-pediatric use are outside this new-population right. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Functional constipation in pediatric patients aged 6-17 years. Adult CIC remains outside this right; the 72 mcg product has both uses. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | 2017-08-30 | SCOPE_CONTEXT | Active-moiety-wide regulatory exclusivity. NUMBRINO shares the cocaine NCE barrier originating with GOPRELTO; its listed NCE end is not a fresh five-year term from its 2020 approval. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | 2020-01-25 | SCOPE_CONTEXT | 72 mcg strength for adult CIC. Full approved scope at the 2017 strength approval; not a barrier for the pediatric FC indication added in 2023/2026. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_STATUS | 2026-09-24 | DECISION_BASIS | Exact-product FDA Final ANDA approval and AB/RLD mapping verified; Authorized Generic and Tentative Approval excluded. | Source |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.