Product profile · United States
SPIRIVA RESPIMAT
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2019 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6176442 | 2016-05-31 | DP — | N | N | DP_DEVICE Nozzle-holder device requires frustum-shaped recess, fluidic component and surrounding elastomeric component exposed to pressurized fluid. | — | — | — |
| US7246615 | 2016-05-31 | DP — | N | N | DP_DEVICE Spray generator combines reservoir, spring-driven piston/cylinder pressure chamber and joined grooved nozzle members. | — | — | — |
| US5964416 | 2016-10-04 | DP — | N | N | DP_DEVICE Atomizer independent claim requires housing, nozzle, cylinder, hollow piston, movable valve, spring housing and blocking mechanism. | — | — | — |
| US6726124 | 2016-10-04 | DP — | N | N | DP_DEVICE Pressurizing device claims protect hollow piston, coaxial movable valve/undercut peg and stop/sealing structures, or displacement body and flow channel. | — | — | — |
| US7104470 | 2016-10-04 | DP — | N | N | DP_DEVICE Replaceable atomizer unit requires stable outer/collapsible inner portions, stopper and bore for reciprocating hollow piston; drug names in dependent claim3 do not create compound claims. | — | — | — |
| US6453795 | 2016-12-05 | DP — | N | N | DP_DEVICE Locking/stressing mechanism requires spring-actuated output member, abutments, screw thrust transmission and displaceable locking/release arrangement. | — | — | — |
| US6149054 | 2016-12-16 | DP — | N | N | DP_DEVICE Mechanical counter requires threaded spindle, rotary mountings, projection/tooth drive, cursor and scale linked to relative rotation of housing portions. | — | — | — |
| US6846413 | 2019-02-28 | DP/PED — | N | N | DP_DEVICE Microstructured filter claims require base/cover plates, integral projections in zigzag rows, passages and inlet/outlet slots. | — | 2019-02-28 | — |
| US6977042 | 2019-02-28 | DP/PED — | N | N | DP_DEVICE Microstructured filter claims protect integral projections and passages between base/cover plates in zigzag arrangement. | — | 2019-02-28 | — |
| US7802568 | 2019-08-26 | DP/PED — | N | N | DP_DEVICE Releasable liquid-cartridge connection requires discrete snap hooks, groove and one-piece vertical extensions/draw-off connector. | — | 2019-08-26 | — |
| US6988496 | 2020-08-23 | DP/PED — | N | N | DP_DEVICE Liquid cartridge with stiff casing, shape-stable container, collapsible bag, stopper and releasable connection to dispensing device. | — | 2020-08-23 | — |
| US7988001 | 2022-02-04 | DP/PED — | N | N | DP_DEVICE Container claims require rigid outer container, pressure-equalization opening and inner bag fixed in a seam. | — | 2022-02-04 | — |
| US7284474 | 2025-02-26 | DP/PED — | N | N | DP_DEVICE Piston-pumping system requires O-ring nitrogen permeability 100-500 units, radial compression below30% and groove fill above90%. | — | 2025-02-26 | — |
| US7896264 | 2025-11-26 | DP/PED — | N | N | DP_DEVICE Microstructured nozzle combines zigzag main filter and filtrate chamber with pillar elements and specified effective flow-area relationship. | — | 2025-11-26 | — |
| 7396341 | 2027-04-10 | DP/PED — | N | N | DP_DEVICE Counter-actuated blocking device for rotating housing and locking/stressing apparatus; use claims inherit the specified mechanism. | — | 2027-04-10 | — |
| 9027967 | 2027-09-30 | DP/PED — | N | N | DP_DEVICE Nozzle-clamping apparatus/process claims require chamfered annular elastomer, nozzle and deforming annular mating projection. | — | 2027-09-30 | — |
| 7837235 | 2028-09-13 | DP/PED — | N | N | DP_DEVICE Nozzle clamping apparatus requires holder, mating member with annular projection, elastomeric part and union member causing deformation. | — | 2028-09-13 | — |
| 8733341 | 2031-04-16 | DP/PED — | N | N | DP_DEVICE Atomizer and operation claims require preliminary conveying-tube movement and a small fluid amount rinsing the nozzle before full-dose delivery. | — | 2031-04-16 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2015-09-15 | 2018-09-15 | COMBINATION_COMPONENT_PARTIAL_POPULATION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Y | N | — | Source | |
| COMBINATION_NP_NPP_PED | 2017-02-15 | 2019-03-15 | 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. NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Y | Y | 2019-03-15 | Source | |
| PED | 2018-09-16 | 2019-03-15 | ATTACHED_EXTENSION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | N | N | — | Source | |
| NPP | 2017-02-15 | 2020-02-15 | COMBINATION_COMPONENT_PARTIAL_POPULATION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Y | N | — | Source | |
| PED | 2020-02-16 | 2020-08-15 | ATTACHED_EXTENSION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | 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 (24)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2016-05-31 | LISTING_CONTEXT | Nozzle-holder device requires frustum-shaped recess, fluidic component and surrounding elastomeric component exposed to pressurized fluid. | Source |
| PATENT | 2016-05-31 | LISTING_CONTEXT | Spray generator combines reservoir, spring-driven piston/cylinder pressure chamber and joined grooved nozzle members. | Source |
| PATENT | 2016-10-04 | LISTING_CONTEXT | Pressurizing device claims protect hollow piston, coaxial movable valve/undercut peg and stop/sealing structures, or displacement body and flow channel. | Source |
| PATENT | 2016-10-04 | LISTING_CONTEXT | Replaceable atomizer unit requires stable outer/collapsible inner portions, stopper and bore for reciprocating hollow piston; drug names in dependent claim3 do not create compound claims. | Source |
| PATENT | 2016-10-04 | LISTING_CONTEXT | Atomizer independent claim requires housing, nozzle, cylinder, hollow piston, movable valve, spring housing and blocking mechanism. | Source |
| PATENT | 2016-12-05 | LISTING_CONTEXT | Locking/stressing mechanism requires spring-actuated output member, abutments, screw thrust transmission and displaceable locking/release arrangement. | Source |
| PATENT | 2016-12-16 | LISTING_CONTEXT | Mechanical counter requires threaded spindle, rotary mountings, projection/tooth drive, cursor and scale linked to relative rotation of housing portions. | Source |
| PATENT | 2019-02-28 | LISTING_CONTEXT | Microstructured filter claims protect integral projections and passages between base/cover plates in zigzag arrangement. | Source |
| PATENT | 2019-02-28 | LISTING_CONTEXT | Microstructured filter claims require base/cover plates, integral projections in zigzag rows, passages and inlet/outlet slots. | Source |
| PATENT | 2019-08-26 | FTO_TAIL | Releasable liquid-cartridge connection requires discrete snap hooks, groove and one-piece vertical extensions/draw-off connector. | Source |
| PATENT | 2020-08-23 | FTO_TAIL | Liquid cartridge with stiff casing, shape-stable container, collapsible bag, stopper and releasable connection to dispensing device. | Source |
| PATENT | 2022-02-04 | FTO_TAIL | Container claims require rigid outer container, pressure-equalization opening and inner bag fixed in a seam. | Source |
| PATENT | 2025-02-26 | FTO_TAIL | Piston-pumping system requires O-ring nitrogen permeability 100-500 units, radial compression below30% and groove fill above90%. | Source |
| PATENT | 2025-11-26 | FTO_TAIL | Microstructured nozzle combines zigzag main filter and filtrate chamber with pillar elements and specified effective flow-area relationship. | Source |
| PATENT | 2027-04-10 | FTO_TAIL | Counter-actuated blocking device for rotating housing and locking/stressing apparatus; use claims inherit the specified mechanism. | Source |
| PATENT | 2027-09-30 | FTO_TAIL | Nozzle-clamping apparatus/process claims require chamfered annular elastomer, nozzle and deforming annular mating projection. | Source |
| PATENT | 2028-09-13 | FTO_TAIL | Nozzle clamping apparatus requires holder, mating member with annular projection, elastomeric part and union member causing deformation. | Source |
| PATENT | 2031-04-16 | FTO_TAIL | Atomizer and operation claims require preliminary conveying-tube movement and a small fluid amount rinsing the nozzle before full-dose delivery. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ATTACHED_EXTENSION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ATTACHED_EXTENSION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | COMBINATION_COMPONENT_PARTIAL_POPULATION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | COMBINATION_COMPONENT_PARTIAL_POPULATION; NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Source |
| REGULATORY_EXCLUSIVITY | 2019-03-15 | 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. NP plus its PED and NPP plus its PED jointly cover maintenance asthma from age6 for exact1.25mcg strength. Union end2019-03-15; later pediatric tail2020-08-15. COPD belongs to2.5mcg product001. | Source |
| REGULATORY_STATUS | 2019-03-15 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2019 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.