LINZESS
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Final ANDA candidate 209564/001 on 2021-02-09. Source-level RLD/TE screen; earliest Final and exact Product source reference require independent review.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7304036 | 2026-08-30 | DS/DP/U U-1516 | — | — | — | — | — | — |
| 7304036 | 2026-08-30 | DS/DP/U U-1278 | — | — | — | — | — | — |
| 7304036 | 2026-08-30 | DS/DP/U U-4345 | — | — | — | — | — | — |
| 7304036 | 2027-02-28 | — — | — | — | — | — | 2027-02-28 | — |
| 8933030 | 2031-02-17 | DP/U U-4345 | — | — | — | — | — | — |
| 8933030 | 2031-08-17 | — — | — | — | — | — | 2031-08-17 | — |
| 8748573 | 2031-10-30 | U U-4345 | — | — | — | — | — | — |
| 8748573 | 2031-10-30 | U U-1515 | — | — | — | — | — | — |
| 8748573 | 2031-10-30 | U U-1516 | — | — | — | — | — | — |
| 8802628 | 2031-10-30 | DP — | — | — | — | — | — | — |
| 8748573 | 2032-04-30 | — — | — | — | — | — | 2032-04-30 | — |
| 8802628 | 2032-04-30 | — — | — | — | — | — | 2032-04-30 | — |
| 9708371 | 2033-08-16 | DP/U U-1515 | — | — | — | — | — | — |
| 9708371 | 2033-08-16 | DP/U U-1516 | — | — | — | — | — | — |
| 9708371 | 2033-08-16 | DP/U U-4345 | — | — | — | — | — | — |
| 9708371 | 2034-02-16 | — — | — | — | — | — | 2034-02-16 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-921 | — | 2026-06-12 | — | — | — | — | Source | |
| NPP | — | 2028-11-04 | — | — | — | — | Source | |
| PED | — | 2029-05-04 | — | — | — | — | Source |
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 |
|---|---|---|---|---|---|---|---|
| 209564 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-02-09 | — | MYLAN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209611 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-02-07 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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 |
|---|---|---|---|---|---|---|
| 209564 / 001 | MYLAN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-02-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209611 / 001 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-02-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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.