ASMANEX HFA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2014 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5889015 | 2014-07-27 | PED — | N | Y | DS_EQUIVALENT Broad independent methods cover daily inhaled aerosolized mometasone for corticosteroid-responsive lower-airway disease, expressly including asthma and metered-dose delivery. ASMANEX HFA sole maintenance/prophylactic asthma indication and local inhaled corticosteroid use correspond; no alternative approved disease remains for label carving. | — | 2014-07-27 | — |
| US6057307 | 2014-07-27 | PED — | N | Y | DS_EQUIVALENT Independent methods cover initial or maintenance treatment of corticosteroid-responsive lower-airway disease using inhaled aerosolized mometasone at least daily, explicitly including asthma and pressurized MDI delivery. ASMANEX HFA sole approved maintenance asthma use corresponds. | — | 2014-07-27 | — |
| US6365581 | 2014-07-27 | PED — | N | Y | DS_EQUIVALENT Independent method claim1 treats corticosteroid-responsive lower-airway/lung disease by aerosolized mometasone with negligible systemic effects; dependent claim3 expressly identifies asthma. The ASMANEX HFA sole local inhaled maintenance/prophylactic asthma indication corresponds. Systemic-effect language remains an express claim condition, not a claim of zero systemic exposure in every patient. | — | 2014-07-27 | — |
| US6068832 | 2017-08-27 | DP/U U-645 | N | N | DP_U Mometasone HFA227 aerosol with1–10 wt% ethanol and a drug/ethanol concentration condition. Treatment claim8 incorporates the quantitative suspension recipe; not an unrestricted mometasone substance or clinical method. | — | — | — |
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. | ||||||||
2026-10-12 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · 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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2014-07-27 | CANONICAL_ANCHOR | Independent method claim1 treats corticosteroid-responsive lower-airway/lung disease by aerosolized mometasone with negligible systemic effects; dependent claim3 expressly identifies asthma. The ASMANEX HFA sole local inhaled maintenance/prophylactic asthma indication corresponds. Systemic-effect language remains an express claim condition, not a claim of zero systemic exposure in every patient. | Source |
| PATENT | 2014-07-27 | CANONICAL_ANCHOR | Independent methods cover initial or maintenance treatment of corticosteroid-responsive lower-airway disease using inhaled aerosolized mometasone at least daily, explicitly including asthma and pressurized MDI delivery. ASMANEX HFA sole approved maintenance asthma use corresponds. | Source |
| PATENT | 2014-07-27 | CANONICAL_ANCHOR | Broad independent methods cover daily inhaled aerosolized mometasone for corticosteroid-responsive lower-airway disease, expressly including asthma and metered-dose delivery. ASMANEX HFA sole maintenance/prophylactic asthma indication and local inhaled corticosteroid use correspond; no alternative approved disease remains for label carving. | Source |
| PATENT | 2017-08-27 | FTO_TAIL | Mometasone HFA227 aerosol with1–10 wt% ethanol and a drug/ethanol concentration condition. Treatment claim8 incorporates the quantitative suspension recipe; not an unrestricted mometasone substance or clinical method. | Source |
| REGULATORY_STATUS | 2014-07-27 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2014 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. | 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.