Product profile · United States
PROAIR DIGIHALER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_DISCONTINUED; RIGHTS_CANONICAL=2018 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6701917 | 2021-06-23 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US6718972 | 2021-06-23 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US6748947 | 2021-06-23 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US6871646 | 2021-06-23 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US8006690 | 2021-06-23 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US7540282 | 2023-05-06 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US10765820 | 2025-05-19 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US9463288 | 2025-05-19 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US8651103 | 2028-03-26 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| 10022510 | 2031-05-18 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US10124131 | 2031-05-18 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US9731087 | 2031-05-18 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US9216260 | 2031-06-28 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| 10561808 | 2032-01-01 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US8978966 | 2032-01-13 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US9782550 | 2035-08-28 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US9782551 | 2035-08-28 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| 10918816 | 2035-12-14 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US10569034 | 2036-08-16 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US11351317 | 2038-02-10 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US11357935 | 2038-09-24 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US11000653 | 2038-12-18 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| 11344685 | 2039-09-26 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US11439777 | 2040-05-24 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US11464923 | 2040-06-19 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| 11173259 | 2040-07-06 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
| US11266796 | 2041-02-22 | FDA_OB_HISTORICAL — | N | N | DP Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | — | — | — |
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_AND_MONTHLY_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 (28)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2021-06-23 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2021-06-23 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2023-05-06 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2025-05-19 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2025-05-19 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2028-03-26 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2031-05-18 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2031-06-28 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2032-01-01 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2032-01-13 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2035-08-28 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2035-08-28 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2035-12-14 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2036-08-16 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2038-02-10 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2038-09-24 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2038-12-18 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2039-09-26 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2040-05-24 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2040-06-19 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2040-07-06 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| PATENT | 2041-02-22 | FTO_TAIL | Formulation/film/depot/inhaler device claims; not drug substance or full-label use. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA_DISCONTINUED; RIGHTS_CANONICAL=2018 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK | 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.