Product profile · United States
DULERA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_RIGHTS. Canonical anchor 2020-11-21; tails [{"kind":"REGULATORY_EXCLUSIVITY","number_or_code":"M-214","date":"2020-12-20"},{"kind":"REGULATORY_EXCLUSIVITY","number_or_code":"PED","date":"2021-06-20"}]
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5889015 | 2014-01-27 | U U-1068 | N | Y | DS_EQUIVALENT Inhaled mometasone treatment of corticosteroid-responsive lower-airway disease, including asthma. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | — | — |
| US6057307 | 2014-01-27 | DP/U U-1068 | N | Y | DS_EQUIVALENT Mometasone inhalation treatment of corticosteroid-responsive disease. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | — | — |
| US6677323 | 2014-01-27 | U U-1068 | N | Y | DS_EQUIVALENT Mometasone inhalation methods including asthma and once- or twice-daily administration. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | — | — |
| US5889015 | 2014-07-27 | PED — | N | Y | DS_EQUIVALENT Inhaled mometasone treatment of corticosteroid-responsive lower-airway disease, including asthma. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | 2014-07-27 | — |
| US6057307 | 2014-07-27 | PED — | N | Y | DS_EQUIVALENT Mometasone inhalation treatment of corticosteroid-responsive disease. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | 2014-07-27 | — |
| US6068832 | 2017-08-27 | DP/U U-1068 | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US7067502 | 2020-05-21 | DP/U U-1068 | N | Y | DS_EQUIVALENT Formoterol/mometasone composition and airway-disease treatment; independent method claim 17 is broader than the formulation claims. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | — | — |
| US7566705 | 2020-05-21 | DP/U U-1068 | N | N | DP_U Formoterol/mometasone composition and airway-disease treatment; method claim 18 requires synergistically effective amounts. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US7067502 | 2020-11-21 | PED — | N | Y | DS_EQUIVALENT Formoterol/mometasone composition and airway-disease treatment; independent method claim 17 is broader than the formulation claims. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | — | 2020-11-21 | — |
| US7566705 | 2020-11-21 | PED — | N | N | DP_U Formoterol/mometasone composition and airway-disease treatment; method claim 18 requires synergistically effective amounts. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | 2020-11-21 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NC | 2010-06-22 | 2013-06-22 | Original new dosage form, new combination or exact new product approval; covers its approved formulation/use scope at this original approval. | Y | Y | 2013-06-22 | Source | |
| M-214 | 2017-12-20 | 2020-12-20 | Safety/efficacy trial information concerning serious asthma-related events in the clinical-trials section; no new full asthma indication. | N | N | — | Source | |
| PED | 2020-12-20 | 2021-06-20 | Six-month extension attached to M-214; retains the underlying partial labeling/indication scope and is not an independent full-scope anchor. | 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 (14)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2014-01-27 | LISTING_CONTEXT | Inhaled mometasone treatment of corticosteroid-responsive lower-airway disease, including asthma. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| PATENT | 2014-01-27 | LISTING_CONTEXT | Mometasone inhalation treatment of corticosteroid-responsive disease. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| PATENT | 2014-01-27 | LISTING_CONTEXT | Mometasone inhalation methods including asthma and once- or twice-daily administration. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| PATENT | 2014-07-27 | LISTING_CONTEXT | Mometasone inhalation treatment of corticosteroid-responsive disease. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| PATENT | 2014-07-27 | LISTING_CONTEXT | Inhaled mometasone treatment of corticosteroid-responsive lower-airway disease, including asthma. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| PATENT | 2017-08-27 | LISTING_CONTEXT | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2020-05-21 | LISTING_CONTEXT | Formoterol/mometasone composition and airway-disease treatment; method claim 18 requires synergistically effective amounts. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2020-05-21 | LISTING_CONTEXT | Formoterol/mometasone composition and airway-disease treatment; independent method claim 17 is broader than the formulation claims. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| PATENT | 2020-11-21 | LISTING_CONTEXT | Formoterol/mometasone composition and airway-disease treatment; method claim 18 requires synergistically effective amounts. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2020-11-21 | CANONICAL_ANCHOR | Formoterol/mometasone composition and airway-disease treatment; independent method claim 17 is broader than the formulation claims. Asthma treatment encompasses the approved DULERA indication; combination treatment does not escape the broad method claim. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Safety/efficacy trial information concerning serious asthma-related events in the clinical-trials section; no new full asthma indication. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month extension attached to M-214; retains the underlying partial labeling/indication scope and is not an independent full-scope anchor. | Source |
| REGULATORY_EXCLUSIVITY | 2013-06-22 | CANONICAL_ANCHOR | Original new dosage form, new combination or exact new product approval; covers its approved formulation/use scope at this original approval. | Source |
| REGULATORY_STATUS | 2020-11-21 | DECISION_BASIS | POST_ANCHOR_RIGHTS. Canonical anchor 2020-11-21; tails [{"kind":"REGULATORY_EXCLUSIVITY","number_or_code":"M-214","date":"2020-12-20"},{"kind":"REGULATORY_EXCLUSIVITY","number_or_code":"PED","date":"2021-06-20"}] | 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.