Product profile · United States
BYDUREON
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_DISCONTINUED; FDA DISC action month 2021-02
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 6515117 | 2025-10-04 | DS/DP/U U-2588 | — | — | — | — | — | — |
| 6515117 | 2026-04-04 | — — | — | — | — | — | 2026-04-04 | — |
| 6515117 | 2026-04-04 | ORANGE_BOOK U-2588 | N | N | U English description not available. | — | 2026-04-04 | — |
| 8329648 | 2026-08-18 | U U-2590 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-2594 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-3189 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-3190 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-2588 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-2596 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-2595 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-2589 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-3188 | — | — | — | — | — | — |
| 8329648 | 2026-08-18 | U U-2593 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-2589 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-3188 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-3189 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-2590 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-2593 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-3190 | — | — | — | — | — | — |
| 8906851 | 2026-08-18 | U U-2588 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2588 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2596 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2595 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2593 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2590 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2589 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-2594 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-3189 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-3188 | — | — | — | — | — | — |
| 9884092 | 2026-08-18 | U U-3190 | — | — | — | — | — | — |
| 8329648 | 2027-02-18 | — — | — | — | — | — | 2027-02-18 | — |
| 8329648 | 2027-02-18 | ORANGE_BOOK U-2588,U-2589,U-2590,U-2593,U-2594,U-2595,U-2596,U-3188,U-3189,U-3190 | N | N | U English description not available. | — | 2027-02-18 | — |
| 8906851 | 2027-02-18 | — — | — | — | — | — | 2027-02-18 | — |
| 8906851 | 2027-02-18 | ORANGE_BOOK U-2588,U-2589,U-2590,U-2593,U-3188,U-3189,U-3190 | N | N | U English description not available. | — | 2027-02-18 | — |
| 9884092 | 2027-02-18 | — — | — | — | — | — | 2027-02-18 | — |
| 9884092 | 2027-02-18 | ORANGE_BOOK U-2588,U-2589,U-2590,U-2593,U-2594,U-2595,U-2596,U-3188,U-3189,U-3190 | N | N | U English description not available. | — | 2027-02-18 | — |
| 8501698 | 2027-06-20 | DP/U U-2588 | — | — | — | — | — | — |
| 8501698 | 2027-12-20 | — — | — | — | — | — | 2027-12-20 | — |
| 8501698 | 2027-12-20 | ORANGE_BOOK U-2588 | N | N | U English description not available. | — | 2027-12-20 | — |
| 8361972 | 2028-03-21 | U U-2588 | — | — | — | — | — | — |
| 8361972 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8361972 | 2028-09-21 | ORANGE_BOOK U-2588 | N | N | U English description not available. | — | 2028-09-21 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2012-01-27 | 2015-01-27 | English description not available. | N | N | — | Source | |
| M-162 | 2015-09-24 | 2018-09-24 | INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE | N | N | — | Source | |
| M-212 | 2017-10-20 | 2020-10-20 | INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND EXENATIDE EXTENDED RELEASE | N | N | — | Source | |
| M-224 | 2018-04-02 | 2021-04-02 | INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF EXENATIDE EXTENDED RELEASE AS ADD-ON IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BASAL INSULIN GLARGINE WITH OR WITHOUT METFORMIN | N | N | — | Source | |
| M-240 | 2019-02-15 | 2022-02-15 | INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES | N | N | — | Source | |
| PED | 2023-02-15 | 2023-08-15 | English description not available. | N | N | — | Source | |
| NPP | 2021-07-22 | 2024-07-22 | English description not available. | N | N | — | Source | |
| PED | 2024-07-22 | 2025-01-22 | English description not available. | N | N | — | Source |
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 0 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 |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (15)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-04-04 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-02-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-02-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-02-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-12-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2028-09-21 | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND EXENATIDE EXTENDED RELEASE | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF EXENATIDE EXTENDED RELEASE AS ADD-ON IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BASAL INSULIN GLARGINE WITH OR WITHOUT METFORMIN | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA_DISCONTINUED; FDA DISC action month 2021-02 | 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.