Product profile · United States
QVAR REDIHALER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. FDA Final approval letter for ANDA 213811 explicitly identifies QVAR NDA 020911, not QVAR REDIHALER NDA 207921. The 2025-12-16 Final approval is excluded from this product.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8132712 | 2028-09-07 | DP — | N | N | INHALER_DOSE_COUNTER | — | — | — |
| 8132712 | 2028-09-07 | DP — | N | N | INHALER_DOSE_COUNTER Claim 1 requires an actuator, a ratchet-toothed rotary gear, a display, and a pawl having at least two radially spaced ratchet teeth. It protects a counter design rather than beclomethasone. | — | — | — |
| 10022509 | 2031-05-18 | DP — | N | N | INHALER_DOSE_COUNTER | — | — | — |
| 10022509 | 2031-05-18 | DP — | N | N | INHALER_DOSE_COUNTER Claim 1 requires a tape counter with a stock bobbin and support shaft, a protrusion with tapered edges, and a resilient frictional engagement geometry. | — | — | — |
| 10022510 | 2031-05-18 | DP — | N | N | INHALER_COUNTER_TAPE | — | — | — |
| 10022510 | 2031-05-18 | DP — | N | N | INHALER_COUNTER_TAPE Claim 1 requires an inhaler counter tape with dosing, positioning, size and priming indicia and specified reel/bobbin attachments. It does not claim unrestricted therapeutic use. | — | — | — |
| 10086156 | 2031-05-18 | DP — | N | N | INHALER_COUNTER_ACTUATION | — | — | — |
| 10086156 | 2031-05-18 | DP — | N | N | INHALER_COUNTER_ACTUATION Claim 1 requires ratchet and count pawls, an actuator and a defined canister-fire/count sequence and datum-plane relationship. | — | — | — |
| 10695512 | 2031-05-18 | DP — | N | N | INHALER_CHASSIS_ATTACHMENT | — | — | — |
| 10695512 | 2031-05-18 | DP — | N | N | INHALER_CHASSIS_ATTACHMENT Claim 1 requires a dose-counter chassis mounted through pins/apertures on different sides and a heat-staked attachment. | — | — | — |
| 11395889 | 2031-05-18 | DP — | N | N | INHALER_COUNTER_ANTIBACK_DRIVE | — | — | — |
| 11395889 | 2031-05-18 | DP — | N | N | INHALER_COUNTER_ANTIBACK_DRIVE Claim 1 requires an incremental counter actuator functioning as an anti-back drive and a second anti-back member when the actuator is disengaged. | — | — | — |
| 8931476 | 2031-07-17 | DP — | N | N | INHALER_AIR_INLET_GEOMETRY | — | — | — |
| 8931476 | 2031-07-17 | DP — | N | N | INHALER_AIR_INLET_GEOMETRY Claim 1 requires arrays of elongate inlet apertures opening in two planes and raised formations between apertures to preserve airflow. | — | — | — |
| 10561808 | 2032-01-01 | DP — | N | N | INHALER_COUNTER_REGULATOR | — | — | — |
| 10561808 | 2032-01-01 | DP — | N | N | INHALER_COUNTER_REGULATOR Claim 1 requires an incrementally driven counter display between two stations and a regulator controlling movement at the first station. | — | — | — |
| 11395888 | 2038-01-26 | DP — | N | N | BREATH_ACTUATED_INHALER_FORCE_SYSTEM | — | — | — |
| 11395888 | 2038-01-26 | DP — | N | N | BREATH_ACTUATED_INHALER_FORCE_SYSTEM Claim 1 requires a specific canister travel range, firing force, metering-valve spring, counter biasing element and vacuum chamber force balance. | — | — | — |
| 11793953 | 2038-01-26 | DP — | N | N | INHALER_GAS_LOCK_PREVENTION | — | — | — |
| 11793953 | 2038-01-26 | DP — | N | N | INHALER_GAS_LOCK_PREVENTION Claim 1 requires atmospheric gas entry, valve-stem retraction for a specified interval and reservoir reorientation to displace gas with a specified fluid amount. | — | — | — |
| 12296089 | 2038-01-26 | DP — | N | N | INHALER_GUIDE_RIB_GEOMETRY | — | — | — |
| 12296089 | 2038-01-26 | DP — | N | N | INHALER_GUIDE_RIB_GEOMETRY Claim 1 requires opposed canister guide ribs and a specified ratio of rib-corner distance to spacing relative to the valve-stem block. | — | — | — |
| 10792447 | 2039-01-25 | DP — | N | N | PNEUMATIC_BREATH_ACTUATED_INHALER | — | — | — |
| 10792447 | 2039-01-25 | DP — | N | N | PNEUMATIC_BREATH_ACTUATED_INHALER Claim 1 requires a pneumatic force-holding canister fire system with rest, prepared and fire configurations and a force-retention threshold over five minutes. | — | — | — |
| 11559637 | 2039-07-21 | DP — | N | N | BREATH_ACTUATED_INHALER_LOCK | — | — | — |
| 11559637 | 2039-07-21 | DP — | N | N | BREATH_ACTUATED_INHALER_LOCK Claim 1 requires a body/cap enclosure, a canister fire system and a segmented helical-thread and snap-lock arrangement. | — | — | — |
| 11957832 | 2041-05-05 | DP — | N | N | PNEUMATIC_INHALER_VALVE_PORT | — | — | — |
| 11957832 | 2041-05-05 | DP — | N | N | PNEUMATIC_INHALER_VALVE_PORT Claim 1 requires a valve port with specified surface roughness and boss/orifice volume or cone-angle geometry. | — | — | — |
| 11583643 | 2041-08-19 | DP — | N | N | INHALER_METERING_METHOD | — | — | — |
| 11583643 | 2041-08-19 | DP — | N | N | INHALER_METERING_METHOD Claim 1 requires vaporization, a retracted valve-stem interval of approximately two minutes to twenty-four hours, reorientation and a specified administered fraction of the labeled dose. | — | — | — |
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. | ||||||||
2026-10-11 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 214418 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | AUROLIFE PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213811 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-16 | — | AMNEAL IRELAND 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 |
|---|---|---|---|---|---|---|
| 213811 / 001 | AMNEAL IRELAND LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (16)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-09-07 | FTO_TAIL | Claim 1 requires an actuator, a ratchet-toothed rotary gear, a display, and a pawl having at least two radially spaced ratchet teeth. It protects a counter design rather than beclomethasone. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Claim 1 requires a tape counter with a stock bobbin and support shaft, a protrusion with tapered edges, and a resilient frictional engagement geometry. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Claim 1 requires an inhaler counter tape with dosing, positioning, size and priming indicia and specified reel/bobbin attachments. It does not claim unrestricted therapeutic use. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Claim 1 requires ratchet and count pawls, an actuator and a defined canister-fire/count sequence and datum-plane relationship. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Claim 1 requires an incremental counter actuator functioning as an anti-back drive and a second anti-back member when the actuator is disengaged. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Claim 1 requires a dose-counter chassis mounted through pins/apertures on different sides and a heat-staked attachment. | Source |
| PATENT | 2031-07-17 | FTO_TAIL | Claim 1 requires arrays of elongate inlet apertures opening in two planes and raised formations between apertures to preserve airflow. | Source |
| PATENT | 2032-01-01 | FTO_TAIL | Claim 1 requires an incrementally driven counter display between two stations and a regulator controlling movement at the first station. | Source |
| PATENT | 2038-01-26 | FTO_TAIL | Claim 1 requires opposed canister guide ribs and a specified ratio of rib-corner distance to spacing relative to the valve-stem block. | Source |
| PATENT | 2038-01-26 | FTO_TAIL | Claim 1 requires a specific canister travel range, firing force, metering-valve spring, counter biasing element and vacuum chamber force balance. | Source |
| PATENT | 2038-01-26 | FTO_TAIL | Claim 1 requires atmospheric gas entry, valve-stem retraction for a specified interval and reservoir reorientation to displace gas with a specified fluid amount. | Source |
| PATENT | 2039-01-25 | FTO_TAIL | Claim 1 requires a pneumatic force-holding canister fire system with rest, prepared and fire configurations and a force-retention threshold over five minutes. | Source |
| PATENT | 2039-07-21 | FTO_TAIL | Claim 1 requires a body/cap enclosure, a canister fire system and a segmented helical-thread and snap-lock arrangement. | Source |
| PATENT | 2041-05-05 | FTO_TAIL | Claim 1 requires a valve port with specified surface roughness and boss/orifice volume or cone-angle geometry. | Source |
| PATENT | 2041-08-19 | FTO_TAIL | Claim 1 requires vaporization, a retracted valve-stem interval of approximately two minutes to twenty-four hours, reorientation and a specified administered fraction of the labeled dose. | Source |
| REGULATORY_STATUS | 2017-08-03 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. FDA Final approval letter for ANDA 213811 explicitly identifies QVAR NDA 020911, not QVAR REDIHALER NDA 207921. The 2025-12-16 Final approval is excluded from this product. | 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.