Product profile · United States
GENOSYL
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Available evidence does not establish a full-scope DS/DS-equivalent or full-coverage exclusivity anchor; approval-year DEEP_REVIEW is proposed. Direct Final-ANDA linkage may change the result.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8057742 | 2026-01-18 | U U-3037 | N | N | DEVICE_RESTRICTED_USE | — | — | — |
| 8057742 | 2026-01-18 | U U-3037 | N | N | DEVICE_RESTRICTED_USE Claims 1/19 concern apparatus; independent claims 12/18 pass NO flow over an antioxidant/reducing-agent surface to convert NO2. Broad indication scope does not establish that every product necessarily requires this conversion technology; DS-equivalent N proposed. | — | — | — |
| 7618594 | 2026-10-17 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 7618594 | 2026-10-17 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS NO2 bottle/antioxidant receptacle·calibration apparatus | — | — | — |
| 7947227 | 2026-10-17 | U U-3037 | N | N | DELIVERY_DEVICE_KIT | — | — | — |
| 7947227 | 2026-10-17 | U U-3037 | N | N | DELIVERY_DEVICE_KIT Independent claims 1/20: diffusion cell/permeation tube/receptacle or pressure regulator/antioxidant conversion kit. Not protection of NO itself or every treatment; N/N. | — | — | — |
| 7560076 | 2027-04-21 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 7560076 | 2027-04-21 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS surface-active antioxidant·permeation-cell NO2 conversion apparatus | — | — | — |
| 9701538 | 2029-01-28 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 9701538 | 2029-01-28 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS concentric three-tube cartridge·annular dimensions·reducing agent | — | — | — |
| 10926054 | 2029-08-13 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 10926054 | 2029-08-13 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS Sintered thermoplastic/silica/antioxidant device and manufacturing method. | — | — | — |
| 8944049 | 2029-08-13 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 8944049 | 2029-08-13 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS Porous matrix/diverter variable-width device; patient-interface system is also device-limited. | — | — | — |
| 9604028 | 2029-08-13 | U U-2793 | N | N | DEVICE_RESTRICTED_USE | — | — | — |
| 9604028 | 2029-08-13 | U U-2793 | N | N | DEVICE_RESTRICTED_USE Independent claim 1 requires an NO-delivery device with antioxidant porous matrix, receptacle, diverter, and variable-width space to convert NO2 to NO. Claims 2-9 are dependent. Unavoidable protection across all therapeutic indications is not established; DS-equivalent N. | — | — | — |
| 11511252 | 2029-09-21 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 11511252 | 2029-09-21 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS pressure regulator/diffusion cell/antioxidant receptacle/downstream cartridge | — | — | — |
| 11103669 | 2030-06-21 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 11103669 | 2030-06-21 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS Nose/mouth outlet with porous polymer/silica antioxidant or an NO-releasing polymer cartridge. | — | — | — |
| 8607785 | 2030-07-14 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 8607785 | 2030-07-14 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS Inlet/outlet/diverter and thermoplastic/silica porous-matrix device. | — | — | — |
| 10737051 | 2035-10-20 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 10737051 | 2035-10-20 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS NO2 ampoule/vessel restrictor, leak valve, and shuttle device. | — | — | — |
| 10213572 | 2036-02-12 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS | — | — | — |
| 10213572 | 2036-02-12 | DP — | N | N | DEVICE_OR_DELIVERY_PROCESS sealed cassette/dual cartridge/porous reducing matrix/passages | — | — | — |
| 11672938 | 2040-07-22 | U U-3037 | N | N | DEVICE_STARTUP_PROCESS | — | — | — |
| 11672938 | 2040-07-22 | U U-3037 | N | N | DEVICE_STARTUP_PROCESS Claims 1/5/13: NO-delivery cassette, console, flow sensor, N2O4 vessel, leak testing, and startup. U3037 does not establish protection of every NO treatment. | — | — | — |
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. | ||||||||
2026-10-10 · 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 |
|---|---|---|---|---|---|---|---|
| 207141 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-02 | — | VERO BIOTECH INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203144 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-07-27 | — | AIRGAS THERAPEUTICS LLC | 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 2 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 |
|---|---|---|---|---|---|---|
| 207141 / 002 | VERO BIOTECH INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203144 / 001 | AIRGAS THERAPEUTICS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2023-07-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (14)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-01-18 | FTO_TAIL | Claims 1/19 concern apparatus; independent claims 12/18 pass NO flow over an antioxidant/reducing-agent surface to convert NO2. Broad indication scope does not establish that every product necessarily requires this conversion technology; DS-equivalent N proposed. | Source |
| PATENT | 2026-10-17 | FTO_TAIL | Independent claims 1/20: diffusion cell/permeation tube/receptacle or pressure regulator/antioxidant conversion kit. Not protection of NO itself or every treatment; N/N. | Source |
| PATENT | 2026-10-17 | FTO_TAIL | NO2 bottle/antioxidant receptacle·calibration apparatus | Source |
| PATENT | 2027-04-21 | FTO_TAIL | surface-active antioxidant·permeation-cell NO2 conversion apparatus | Source |
| PATENT | 2029-01-28 | FTO_TAIL | concentric three-tube cartridge·annular dimensions·reducing agent | Source |
| PATENT | 2029-08-13 | FTO_TAIL | Independent claim 1 requires an NO-delivery device with antioxidant porous matrix, receptacle, diverter, and variable-width space to convert NO2 to NO. Claims 2-9 are dependent. Unavoidable protection across all therapeutic indications is not established; DS-equivalent N. | Source |
| PATENT | 2029-08-13 | FTO_TAIL | Sintered thermoplastic/silica/antioxidant device and manufacturing method. | Source |
| PATENT | 2029-08-13 | FTO_TAIL | Porous matrix/diverter variable-width device; patient-interface system is also device-limited. | Source |
| PATENT | 2029-09-21 | FTO_TAIL | pressure regulator/diffusion cell/antioxidant receptacle/downstream cartridge | Source |
| PATENT | 2030-06-21 | FTO_TAIL | Nose/mouth outlet with porous polymer/silica antioxidant or an NO-releasing polymer cartridge. | Source |
| PATENT | 2030-07-14 | FTO_TAIL | Inlet/outlet/diverter and thermoplastic/silica porous-matrix device. | Source |
| PATENT | 2035-10-20 | FTO_TAIL | NO2 ampoule/vessel restrictor, leak valve, and shuttle device. | Source |
| PATENT | 2036-02-12 | FTO_TAIL | sealed cassette/dual cartridge/porous reducing matrix/passages | Source |
| PATENT | 2040-07-22 | FTO_TAIL | Claims 1/5/13: NO-delivery cassette, console, flow sensor, N2O4 vessel, leak testing, and startup. U3037 does not establish protection of every NO treatment. | 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.