Product profile · United States
PROAIR RESPICLICK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2018 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6446627 | 2017-12-18 | DP — | N | N | DP_DEVICE Dose-counter independent claims require ratchet gear, display and reverse-rotation restraint or friction clutch; no albuterol compound or clinical treatment monopoly. | — | — | — |
| US6701917 | 2021-06-23 | DP — | N | N | DP_DEVICE Inhaler counter uses a pawl, bobbin, spool and indicia ribbon; claims protect mechanical counting and cover-linked assembly. | — | — | — |
| US6718972 | 2021-06-23 | DP — | N | N | DP_DEVICE Inhaler dose-metering claims require hinged cover, cup, springs, yoke, ratchet and cams with sequential positions. | — | — | — |
| US6748947 | 2021-06-23 | DP — | N | N | DP_DEVICE Dry-powder de-agglomerator claims require swirl chamber, inlet/outlet ports and fixed oblique vanes. | — | — | — |
| US6871646 | 2021-06-23 | DP — | N | N | DP_DEVICE Independent method de-agglomerates powder through specified colliding airflows, fixed vanes and spiral path. This is a device-operation method, not unrestricted treatment of bronchospasm or exercise-induced bronchospasm. | — | — | — |
| US8006690 | 2021-06-23 | DP — | N | N | DP_DEVICE Independent claims protect inhaler reservoir, movable cup, cup spring and yoke/ratchet mechanisms; later independent claims add cam or de-agglomerator features. | — | — | — |
| US7540282 | 2023-05-06 | DP — | N | N | DP_DEVICE Sealed reservoir inhaler with linear channel, pressure-relief port, conduit and movable cup assembly with two sealing surfaces. | — | — | — |
| US10765820 | 2025-05-19 | DP — | N | N | DP_DEVICE Dry-powder inhalation apparatus requires manually operated external release mechanism and transverse abutment controlling dose-transfer device. | — | — | — |
| US9463288 | 2025-05-19 | DP — | N | N | DP_DEVICE Dry-powder inhaler requires spring-biased transfer device, translating yoke, abutment and sloping ratchet surface. | — | — | — |
| US8651103 | 2028-03-26 | DP — | N | N | DP_DEVICE Dry-powder apparatus requires reservoir, delivery channel, spring-biased dose-transfer device and translating yoke/abutment release mechanism. | — | — | — |
| 10022510 | 2031-05-18 | DP — | N | N | DP_DEVICE Counter tape with dosing, positioning, size and priming indicia, viewing window, reel shaft and stock bobbin. | — | — | — |
| US10124131 | 2031-05-18 | DP — | N | N | DP_DEVICE Tape dose counter with first/second stations and regulator employing projection and wavelike engagement surface. | — | — | — |
| US9731087 | 2031-05-18 | DP — | N | N | DP_DEVICE Counter tape, bobbin bore, support shaft and resilient frictional convex/concave engagement; dependent claims expressly include dry-powder inhalers. | — | — | — |
| US9216260 | 2031-06-28 | DP — | N | N | DP_DEVICE Independent claims protect counter-tape shafts with alternating concave/convex engagement formations, interior wavy surface or socket. | — | — | — |
| 10561808 | 2032-01-01 | DP — | N | N | DP_DEVICE Dose-counter display and drive system move incrementally between two stations, with a regulator acting at the first station. | — | — | — |
| US8978966 | 2032-01-13 | DP — | N | N | DP_DEVICE Dose counter uses incremental counting, tape bobbin/shaft and frictional wavelike engagement surfaces. Broader counter claims remain device claims even when not confined to a pressurized canister. | — | — | — |
| US9782550 | 2035-08-28 | DP — | N | N | DP_DEVICE Inhaler monitoring module requires sensor, wireless transmitter and processor; cover/bellows action meters the dose and changes the module power state. Historical RESPICLICK listing is retained; current RESPICLICK label does not establish the mandatory electronic module. | — | — | — |
| US9782551 | 2035-08-28 | DP — | N | N | DP_DEVICE Inhaler requires processor, pneumatically coupled pressure sensor and wireless transmitter, with cover-triggered power-state change. Historical RESPICLICK listing is retained; do not substitute DIGIHALER electronics for the exact RESPICLICK product. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| COMBINATION_NP_NPP | 2016-04-28 | 2018-03-12 | Full exact-product approved indication and population scope established by the reviewed union of required FDA rights. Meaningful date is the earlier necessary component extended endpoint. Derived review conclusion, not a separate FDA award. Original at-least12-year scope and2016 age4-11 expansion jointly cover both labeled uses from age4. Complete union ends2018-03-12. Preserve the FDA listed end/approval-date discrepancy; no date is silently recalculated. The2020 combined PDF includes both RESPICLICK and DIGIHALER; only the RESPICLICK section is used. | Y | Y | 2018-03-12 | Source | |
| NP | 2015-03-31 | 2018-03-12 | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original at-least12-year scope and2016 age4-11 expansion jointly cover both labeled uses from age4. Complete union ends2018-03-12. Preserve the FDA listed end/approval-date discrepancy; no date is silently recalculated. The2020 combined PDF includes both RESPICLICK and DIGIHALER; only the RESPICLICK section is used. | Y | N | — | Source | |
| NPP | 2016-04-28 | 2019-04-28 | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original at-least12-year scope and2016 age4-11 expansion jointly cover both labeled uses from age4. Complete union ends2018-03-12. Preserve the FDA listed end/approval-date discrepancy; no date is silently recalculated. The2020 combined PDF includes both RESPICLICK and DIGIHALER; only the RESPICLICK section is used. | Y | 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 (22)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2017-12-18 | LISTING_CONTEXT | Dose-counter independent claims require ratchet gear, display and reverse-rotation restraint or friction clutch; no albuterol compound or clinical treatment monopoly. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Inhaler dose-metering claims require hinged cover, cup, springs, yoke, ratchet and cams with sequential positions. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Inhaler counter uses a pawl, bobbin, spool and indicia ribbon; claims protect mechanical counting and cover-linked assembly. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Dry-powder de-agglomerator claims require swirl chamber, inlet/outlet ports and fixed oblique vanes. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Independent claims protect inhaler reservoir, movable cup, cup spring and yoke/ratchet mechanisms; later independent claims add cam or de-agglomerator features. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Independent method de-agglomerates powder through specified colliding airflows, fixed vanes and spiral path. This is a device-operation method, not unrestricted treatment of bronchospasm or exercise-induced bronchospasm. | Source |
| PATENT | 2023-05-06 | FTO_TAIL | Sealed reservoir inhaler with linear channel, pressure-relief port, conduit and movable cup assembly with two sealing surfaces. | Source |
| PATENT | 2025-05-19 | FTO_TAIL | Dry-powder inhaler requires spring-biased transfer device, translating yoke, abutment and sloping ratchet surface. | Source |
| PATENT | 2025-05-19 | FTO_TAIL | Dry-powder inhalation apparatus requires manually operated external release mechanism and transverse abutment controlling dose-transfer device. | Source |
| PATENT | 2028-03-26 | FTO_TAIL | Dry-powder apparatus requires reservoir, delivery channel, spring-biased dose-transfer device and translating yoke/abutment release mechanism. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Counter tape, bobbin bore, support shaft and resilient frictional convex/concave engagement; dependent claims expressly include dry-powder inhalers. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Tape dose counter with first/second stations and regulator employing projection and wavelike engagement surface. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Counter tape with dosing, positioning, size and priming indicia, viewing window, reel shaft and stock bobbin. | Source |
| PATENT | 2031-06-28 | FTO_TAIL | Independent claims protect counter-tape shafts with alternating concave/convex engagement formations, interior wavy surface or socket. | Source |
| PATENT | 2032-01-01 | FTO_TAIL | Dose-counter display and drive system move incrementally between two stations, with a regulator acting at the first station. | Source |
| PATENT | 2032-01-13 | FTO_TAIL | Dose counter uses incremental counting, tape bobbin/shaft and frictional wavelike engagement surfaces. Broader counter claims remain device claims even when not confined to a pressurized canister. | Source |
| PATENT | 2035-08-28 | FTO_TAIL | Inhaler monitoring module requires sensor, wireless transmitter and processor; cover/bellows action meters the dose and changes the module power state. Historical RESPICLICK listing is retained; current RESPICLICK label does not establish the mandatory electronic module. | Source |
| PATENT | 2035-08-28 | FTO_TAIL | Inhaler requires processor, pneumatically coupled pressure sensor and wireless transmitter, with cover-triggered power-state change. Historical RESPICLICK listing is retained; do not substitute DIGIHALER electronics for the exact RESPICLICK product. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original at-least12-year scope and2016 age4-11 expansion jointly cover both labeled uses from age4. Complete union ends2018-03-12. Preserve the FDA listed end/approval-date discrepancy; no date is silently recalculated. The2020 combined PDF includes both RESPICLICK and DIGIHALER; only the RESPICLICK section is used. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | COMBINATION_COMPONENT_PARTIAL_POPULATION; Original at-least12-year scope and2016 age4-11 expansion jointly cover both labeled uses from age4. Complete union ends2018-03-12. Preserve the FDA listed end/approval-date discrepancy; no date is silently recalculated. The2020 combined PDF includes both RESPICLICK and DIGIHALER; only the RESPICLICK section is used. | Source |
| REGULATORY_EXCLUSIVITY | 2018-03-12 | CANONICAL_ANCHOR | Full exact-product approved indication and population scope established by the reviewed union of required FDA rights. Meaningful date is the earlier necessary component extended endpoint. Derived review conclusion, not a separate FDA award. Original at-least12-year scope and2016 age4-11 expansion jointly cover both labeled uses from age4. Complete union ends2018-03-12. Preserve the FDA listed end/approval-date discrepancy; no date is silently recalculated. The2020 combined PDF includes both RESPICLICK and DIGIHALER; only the RESPICLICK section is used. | Source |
| REGULATORY_STATUS | 2018-03-12 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2018 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.