OPSYNVI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2031. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: 2029-10-18. Exclusivity anchor: 2031-09-22. Anchor date: 2031-09-22. Patent tail: no. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7094781 | 2025-12-05 | DS/DP — | — | — | — | — | — | — |
| 7094781 | 2026-06-05 | — — | — | — | — | — | 2026-06-05 | — |
| 7094781 | 2026-06-05 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2026-06-05 | — |
| 10946015 | 2026-09-11 | DP/U U-3881 | — | — | — | — | — | — |
| 10946015 | 2027-03-11 | — — | — | — | — | — | 2027-03-11 | — |
| 10946015 | 2027-03-11 | ORANGE_BOOK U-3881 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2027-03-11 | — |
| 8268847 | 2029-04-18 | DP/U U-3882 | — | — | — | — | — | — |
| 8268847 | 2029-10-18 | — — | — | — | — | — | 2029-10-18 | — |
| 8268847 | 2029-10-18 | ORANGE_BOOK U-3882 | N | Y | DS_EQUIVALENT Claim 1: macitentan + PDE5 inhibitor for a disease involving vasoconstriction; the sole approved PAH indication is encompassed. | — | 2029-10-18 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | — | 2027-03-22 | — | — | — | — | Source | |
| NP | — | 2027-03-22 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| PED | — | 2027-09-22 | — | — | — | — | Source | |
| PED | — | 2027-09-22 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| ODE-475 | — | 2031-03-22 | — | — | — | — | Source | |
| ODE-475 | — | 2031-03-22 | Adult PAH WHO Group I/FC II-III; sole OPSYNVI indication matched to official OOPD. | Y | Y | 2031-03-22 | — | Source |
| PED | — | 2031-09-22 | — | — | — | — | Source | |
| PED | — | 2031-09-22 | OOPD protected indication exactly matches the sole adult PAH WHO Group I/FC II-III label indication. Associated listed pediatric extension; not an independent FDA indication grant. | Y | Y | 2031-09-22 | — | Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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 (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-06-05 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2027-03-11 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2029-10-18 | CANONICAL_ANCHOR | Claim 1: macitentan + PDE5 inhibitor for a disease involving vasoconstriction; the sole approved PAH indication is encompassed. | Source |
| REGULATORY_STATUS | 2031-09-22 | CANONICAL_DECISION | English description not available. | 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.