Product profile · United States
YUPELRI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7288657 | 2028-10-31 | DS — | Y | Y | TRUE_DS | — | — | — |
| 7288657 | 2028-10-31 | DS — | Y | Y | TRUE_DS Independent claim 14 explicitly names revefenacin or acceptable salt; claim 13 and genus also include it without crystal, formulation or indication restriction. | — | — | — |
| 10550081 | 2030-07-14 | DS — | N | N | CRYSTAL | — | — | — |
| 10550081 | 2030-07-14 | DS — | N | N | CRYSTAL Revefenacin crystalline free base defined by melting/DSC properties. | — | — | — |
| 11008289 | 2030-07-14 | U U-2440 | N | N | CRYSTAL_PROCESS_USE | — | — | — |
| 11008289 | 2030-07-14 | U U-2440 | N | N | CRYSTAL_PROCESS_USE COPD method requires dissolving a specifically defined crystalline revefenacin free base and nebulization. | — | — | — |
| 11691948 | 2030-07-14 | DP — | N | N | CRYSTAL_PROCESS_FORMULATION | — | — | — |
| 11691948 | 2030-07-14 | DP — | N | N | CRYSTAL_PROCESS_FORMULATION Revefenacin dissolved crystalline free base with XRPD/melting and pH or process restrictions, including corrected claims. | — | — | — |
| 11858898 | 2030-07-14 | DS/DP/U U-2440 | N | N | CRYSTAL_USE | — | — | — |
| 11858898 | 2030-07-14 | DS/DP/U U-2440 | N | N | CRYSTAL_USE Revefenacin COPD treatment requires specific crystalline free-base XRPD or DSC properties; no automatic DS equivalence. | — | — | — |
| 9765028 | 2030-07-14 | DS — | N | N | CRYSTAL | — | — | — |
| 9765028 | 2030-07-14 | DS — | N | N | CRYSTAL Revefenacin crystalline Form III defined by XRPD patterns, including corrected claims. | — | — | — |
| 8541451 | 2031-08-25 | DS — | N | N | CRYSTAL | — | — | — |
| 8541451 | 2031-08-25 | DS — | N | N | CRYSTAL Revefenacin free-base crystalline Forms III/IV defined by XRPD and melting points. | — | — | — |
| 12048692 | 2039-08-29 | U U-2440 | N | N | LIMITED_USE | — | — | — |
| 12048692 | 2039-08-29 | U U-2440 | N | N | LIMITED_USE Corrected claim 1 remains limited to severe/very severe COPD, FEV1 below 50 percent and low inspiratory flow; not all approved COPD patients. | — | — | — |
| 12285417 | 2039-08-29 | U U-2440 | N | N | LIMITED_USE | — | — | — |
| 12285417 | 2039-08-29 | U U-2440 | N | N | LIMITED_USE Revefenacin nebulization restricted to severe COPD with low FEV1 and low inspiratory flow. | — | — | — |
| 11484531 | 2039-10-23 | U U-2440 | N | N | LIMITED_USE | — | — | — |
| 11484531 | 2039-10-23 | U U-2440 | N | N | LIMITED_USE Revefenacin COPD therapy selected for low peak inspiratory flow and severe FEV1 impairment; not all COPD patients. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2018-11-09 | 2023-11-09 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2023-11-09 | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · 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 |
|---|---|---|---|---|---|---|---|
| 218089 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | MANKIND PHARMA 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 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 (12)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-10-31 | CANONICAL_ANCHOR | Independent claim 14 explicitly names revefenacin or acceptable salt; claim 13 and genus also include it without crystal, formulation or indication restriction. | Source |
| PATENT | 2030-07-14 | FTO_TAIL | Revefenacin crystalline Form III defined by XRPD patterns, including corrected claims. | Source |
| PATENT | 2030-07-14 | FTO_TAIL | COPD method requires dissolving a specifically defined crystalline revefenacin free base and nebulization. | Source |
| PATENT | 2030-07-14 | FTO_TAIL | Revefenacin dissolved crystalline free base with XRPD/melting and pH or process restrictions, including corrected claims. | Source |
| PATENT | 2030-07-14 | FTO_TAIL | Revefenacin COPD treatment requires specific crystalline free-base XRPD or DSC properties; no automatic DS equivalence. | Source |
| PATENT | 2030-07-14 | FTO_TAIL | Revefenacin crystalline free base defined by melting/DSC properties. | Source |
| PATENT | 2031-08-25 | FTO_TAIL | Revefenacin free-base crystalline Forms III/IV defined by XRPD and melting points. | Source |
| PATENT | 2039-08-29 | FTO_TAIL | Revefenacin nebulization restricted to severe COPD with low FEV1 and low inspiratory flow. | Source |
| PATENT | 2039-08-29 | FTO_TAIL | Corrected claim 1 remains limited to severe/very severe COPD, FEV1 below 50 percent and low inspiratory flow; not all approved COPD patients. | Source |
| PATENT | 2039-10-23 | FTO_TAIL | Revefenacin COPD therapy selected for low peak inspiratory flow and severe FEV1 impairment; not all COPD patients. | Source |
| REGULATORY_EXCLUSIVITY | 2023-11-09 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2028-10-31 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | 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.