AUSTEDO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
ANDA 215971/002 Final 2024-12-26; FDA RLD brand or first generic source. Exact RLD product and competing same-day/earlier ANDAs should be checked.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8524733 | 2031-04-03 | DS/DP — | — | — | — | — | — | — |
| 8524733 | 2031-10-03 | — — | — | — | — | — | 2031-10-03 | — |
| 11666566 | 2033-09-18 | DP — | — | — | — | — | — | — |
| 9233959 | 2033-09-18 | DP — | — | — | — | — | — | — |
| 9296739 | 2033-09-18 | DP — | — | — | — | — | — | — |
| 9550780 | 2033-09-18 | DS/DP/U U-3055 | — | — | — | — | — | — |
| 9550780 | 2033-09-18 | DS/DP/U U-1995 | — | — | — | — | — | — |
| 9814708 | 2033-09-18 | DP — | — | — | — | — | — | — |
| 11666566 | 2034-03-18 | — — | — | — | — | — | 2034-03-18 | — |
| 9233959 | 2034-03-18 | — — | — | — | — | — | 2034-03-18 | — |
| 9296739 | 2034-03-18 | — — | — | — | — | — | 2034-03-18 | — |
| 9550780 | 2034-03-18 | — — | — | — | — | — | 2034-03-18 | — |
| 9814708 | 2034-03-18 | — — | — | — | — | — | 2034-03-18 | — |
| 10959996 | 2036-03-07 | U U-3055 | — | — | — | — | — | — |
| 11357772 | 2036-03-07 | U U-3055 | — | — | — | — | — | — |
| 11357772 | 2036-03-07 | U U-1995 | — | — | — | — | — | — |
| 11446291 | 2036-03-07 | U U-1995 | — | — | — | — | — | — |
| 11564917 | 2036-03-07 | U U-1995 | — | — | — | — | — | — |
| 11648244 | 2036-03-07 | U U-1995 | — | — | — | — | — | — |
| 12016858 | 2036-03-07 | U U-3055 | — | — | — | — | — | — |
| 12016858 | 2036-03-07 | U U-1995 | — | — | — | — | — | — |
| 10959996 | 2036-09-07 | — — | — | — | — | — | 2036-09-07 | — |
| 11357772 | 2036-09-07 | — — | — | — | — | — | 2036-09-07 | — |
| 11446291 | 2036-09-07 | — — | — | — | — | — | 2036-09-07 | — |
| 11564917 | 2036-09-07 | — — | — | — | — | — | 2036-09-07 | — |
| 11648244 | 2036-09-07 | — — | — | — | — | — | 2036-09-07 | — |
| 12016858 | 2036-09-07 | — — | — | — | — | — | 2036-09-07 | — |
| 11179386 | 2038-03-15 | DP/U U-1995 | — | — | — | — | — | — |
| 11179386 | 2038-03-15 | DP/U U-3055 | — | — | — | — | — | — |
| 11813232 | 2038-03-15 | DP — | — | — | — | — | — | — |
| 11179386 | 2038-09-15 | — — | — | — | — | — | 2038-09-15 | — |
| 11813232 | 2038-09-15 | — — | — | — | — | — | 2038-09-15 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
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 |
|---|---|---|---|---|---|---|---|
| 215971 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2024-12-26 | — | 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 1 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 |
|---|---|---|---|---|---|---|
| 215971 / 002 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-12-26 | 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.