Product profile · United States
ARNUITY ELLIPTA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2021 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5873360 | 2016-02-23 | DP — | N | N | DP_DEVICE Peelable strip/blister medicament pack and inhalation delivery mechanics; no fluticasone chemical substance or asthma treatment monopoly. | — | — | — |
| US7101866 | 2021-08-03 | DS/DP/U U-1559 | Y | N | TRUE_DS Independent claim1 protects fluticasone furoate formulaI and solvates; later claims separately add specific polymorph and formulation limitations. The broad independent claim is not confined to Form1 crystal or an inhaler. | — | — | — |
| US7629335 | 2021-08-03 | DP — | N | N | DP_SOLID_STATE Fluticasone-furoate dry-powder composition/inhaler limited to unsolvated Form1 polymorph identified by18.9-degree XRPD peak, particle size and concentration conditions; distinguish from broad claim1 ofUS7101866. | — | — | — |
| US8113199 | 2027-10-23 | DP — | N | N | DP_DEVICE Mechanical dose counter with rotating count wheels and drive teeth; not drug substance or asthma-treatment method. | — | — | — |
| US8161968 | 2028-02-05 | DP — | N | N | DP_DEVICE Plural-carrier inhaler dispensing mechanism, receiving/release/indexing stations and movable outlet cover. | — | — | — |
| US9333310 | 2028-04-02 | DP/PED — | N | N | DP_DEVICE Blister-sheet driver, shaft/hub and spring mechanics of a medicament dispenser. | — | 2028-04-02 | — |
| US8201556 | 2029-02-05 | DP — | N | N | DP_DEVICE Inhaler sheet driver, hub, shaft and pretensioned torsion-spring mechanism. | — | — | — |
| 8534281 | 2030-03-08 | DP — | N | N | DP_DEVICE Powder-inhaler manifold with specified chimney inlets/exits, chamber and paired blister flow paths. | — | — | — |
| 8746242 | 2031-04-11 | DP/PED — | N | N | DP_DEVICE Inhaler mouthpiece cover positions and coupling to dose actuation; device mechanism cannot become a full-indication clinical-use patent. | — | 2031-04-11 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2014-08-20 | 2017-08-20 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NP covers maintenance asthma treatment in patients at least 12 years old for the exact 100 mcg and 200 mcg products. The 2018 age-5-to-11 expansion uses 50 mcg (product 003), which is not in this batch. NPP through 2021-05-17 is retained on product 001 where FDA listed it, but does not replace the full 100/200 mcg date or migrate to product 002. The 2023 efficacy supplement adds study results, not a new whole-strength indication. | Y | Y | 2017-08-20 | Source | |
| NPP | 2018-05-17 | 2021-05-17 | PARTIAL_PEDIATRIC_POPULATION; NP covers maintenance asthma treatment in patients at least 12 years old for the exact 100 mcg and 200 mcg products. The 2018 age-5-to-11 expansion uses 50 mcg (product 003), which is not in this batch. NPP through 2021-05-17 is retained on product 001 where FDA listed it, but does not replace the full 100/200 mcg date or migrate to product 002. The 2023 efficacy supplement adds study results, not a new whole-strength indication. | N | N | — | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 (12)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2016-02-23 | LISTING_CONTEXT | Peelable strip/blister medicament pack and inhalation delivery mechanics; no fluticasone chemical substance or asthma treatment monopoly. | Source |
| PATENT | 2021-08-03 | LISTING_CONTEXT | Fluticasone-furoate dry-powder composition/inhaler limited to unsolvated Form1 polymorph identified by18.9-degree XRPD peak, particle size and concentration conditions; distinguish from broad claim1 ofUS7101866. | Source |
| PATENT | 2021-08-03 | CANONICAL_ANCHOR | Independent claim1 protects fluticasone furoate formulaI and solvates; later claims separately add specific polymorph and formulation limitations. The broad independent claim is not confined to Form1 crystal or an inhaler. | Source |
| PATENT | 2027-10-23 | FTO_TAIL | Mechanical dose counter with rotating count wheels and drive teeth; not drug substance or asthma-treatment method. | Source |
| PATENT | 2028-02-05 | FTO_TAIL | Plural-carrier inhaler dispensing mechanism, receiving/release/indexing stations and movable outlet cover. | Source |
| PATENT | 2028-04-02 | FTO_TAIL | Blister-sheet driver, shaft/hub and spring mechanics of a medicament dispenser. | Source |
| PATENT | 2029-02-05 | FTO_TAIL | Inhaler sheet driver, hub, shaft and pretensioned torsion-spring mechanism. | Source |
| PATENT | 2030-03-08 | FTO_TAIL | Powder-inhaler manifold with specified chimney inlets/exits, chamber and paired blister flow paths. | Source |
| PATENT | 2031-04-11 | FTO_TAIL | Inhaler mouthpiece cover positions and coupling to dose actuation; device mechanism cannot become a full-indication clinical-use patent. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | PARTIAL_PEDIATRIC_POPULATION; NP covers maintenance asthma treatment in patients at least 12 years old for the exact 100 mcg and 200 mcg products. The 2018 age-5-to-11 expansion uses 50 mcg (product 003), which is not in this batch. NPP through 2021-05-17 is retained on product 001 where FDA listed it, but does not replace the full 100/200 mcg date or migrate to product 002. The 2023 efficacy supplement adds study results, not a new whole-strength indication. | Source |
| REGULATORY_EXCLUSIVITY | 2017-08-20 | CANONICAL_ANCHOR | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NP covers maintenance asthma treatment in patients at least 12 years old for the exact 100 mcg and 200 mcg products. The 2018 age-5-to-11 expansion uses 50 mcg (product 003), which is not in this batch. NPP through 2021-05-17 is retained on product 001 where FDA listed it, but does not replace the full 100/200 mcg date or migrate to product 002. The 2023 efficacy supplement adds study results, not a new whole-strength indication. | Source |
| REGULATORY_STATUS | 2021-08-03 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2021 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. | 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.