ANORO ELLIPTA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
NO_POST_ANCHOR_TAIL; Canonical 2030-11-29; latest tail NO_POST_ANCHOR_TAIL
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8511304 | 2027-06-14 | DP/U U-1476 | — | — | — | — | — | — |
| 8511304 | 2027-12-14 | — — | — | — | — | — | 2027-12-14 | — |
| 8511304 | 2027-12-14 | ORANGE_BOOK U-1476 | N | N | SYSTEM English description not available. | — | 2027-12-14 | — |
| 7488827 | 2027-12-18 | DS/DP — | — | — | — | — | — | — |
| 7488827 | 2027-12-18 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11090294 | 2030-11-29 | U U-3203 | — | — | — | — | — | — |
| 11090294 | 2030-11-29 | ORANGE_BOOK U-3203 | N | Y | DS_EQUIVALENT English description not available. | — | — | — |
| 12396986 | 2030-11-29 | DP — | — | — | — | — | — | — |
| 12396986 | 2030-11-29 | ORANGE_BOOK — | N | Y | DS_EQUIVALENT English description not available. | — | — | — |
| 9750726 | 2030-11-29 | DP — | — | — | — | — | — | — |
| 9750726 | 2030-11-29 | ORANGE_BOOK — | N | Y | DS_EQUIVALENT English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2013-12-18 | 2016-12-18 | English description not available. | N | N | — | Source | |
| NCE | 2013-05-10 | 2018-05-10 | NEW CHEMICAL ENTITY | Y | Y | 2018-05-10 | Source | |
| NCE | 2013-12-18 | 2018-12-18 | NEW CHEMICAL ENTITY | Y | Y | 2018-12-18 | Source | |
| M-245 | 2019-06-09 | 2022-06-09 | ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL | 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 (10)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-12-14 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-12-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-11-29 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2030-11-29 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2030-11-29 | CANONICAL_ANCHOR | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | NEW CHEMICAL ENTITY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | NEW CHEMICAL ENTITY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2030-11-29 | CANONICAL_DECISION | NO_POST_ANCHOR_TAIL; Canonical 2030-11-29; latest tail NO_POST_ANCHOR_TAIL | 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.