Product profile · United States
OPZELURA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2031. Anchor type: DS_EQUIVALENT_PATENT. Patent anchor: 2031-05-20. Exclusivity anchor: not recorded. Anchor date: 2031-05-20. Patent tail: yes. 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 |
|---|---|---|---|---|---|---|---|---|
| 10639310 | 2026-12-12 | U U-3229 | — | — | — | — | — | — |
| 9079912 | 2026-12-12 | U U-3229 | — | — | — | — | — | — |
| 9079912 | 2026-12-12 | U U-3404 | — | — | — | — | — | — |
| 9974790 | 2026-12-12 | U U-3404 | — | — | — | — | — | — |
| 9974790 | 2026-12-12 | U U-3229 | — | — | — | — | — | — |
| 10639310 | 2027-06-12 | — — | — | — | — | — | 2027-06-12 | — |
| 10639310 | 2027-06-12 | ORANGE_BOOK U-3229 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2027-06-12 | — |
| 9079912 | 2027-06-12 | — — | — | — | — | — | 2027-06-12 | — |
| 9079912 | 2027-06-12 | ORANGE_BOOK U-3229,U-3404 | N | Y | DS_EQUIVALENT Independent claims 1/3: ruxolitinib JAK1/JAK2 inhibition or signal blocking, without indication restriction. | — | 2027-06-12 | — |
| 9974790 | 2027-06-12 | — — | — | — | — | — | 2027-06-12 | — |
| 9974790 | 2027-06-12 | ORANGE_BOOK U-3229,U-3404 | N | Y | DS_EQUIVALENT Ruxolitinib inhibition of JAK1/JAK2 in autoimmune skin disease; includes both current OPZELURA indications. | — | 2027-06-12 | — |
| 7598257 | 2027-12-24 | DS/DP — | — | — | — | — | — | — |
| 8415362 | 2027-12-24 | DS/DP — | — | — | — | — | — | — |
| 10610530 | 2028-06-12 | U U-3404 | — | — | — | — | — | — |
| 10610530 | 2028-06-12 | U U-3229 | — | — | — | — | — | — |
| 8722693 | 2028-06-12 | DS/DP — | — | — | — | — | — | — |
| 8822481 | 2028-06-12 | U U-3229 | — | — | — | — | — | — |
| 8822481 | 2028-06-12 | U U-3404 | — | — | — | — | — | — |
| 7598257 | 2028-06-24 | — — | — | — | — | — | 2028-06-24 | — |
| 7598257 | 2028-06-24 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-06-24 | — |
| 8415362 | 2028-06-24 | — — | — | — | — | — | 2028-06-24 | — |
| 8415362 | 2028-06-24 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-06-24 | — |
| 10610530 | 2028-12-12 | — — | — | — | — | — | 2028-12-12 | — |
| 10610530 | 2028-12-12 | ORANGE_BOOK U-3229,U-3404 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2028-12-12 | — |
| 8722693 | 2028-12-12 | — — | — | — | — | — | 2028-12-12 | — |
| 8722693 | 2028-12-12 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2028-12-12 | — |
| 8822481 | 2028-12-12 | — — | — | — | — | — | 2028-12-12 | — |
| 8822481 | 2028-12-12 | ORANGE_BOOK U-3229,U-3404 | N | Y | DS_EQUIVALENT Independent claims 1/8/15: ruxolitinib phosphate inhibition/modulation of JAK1/JAK2, no disease restriction; all approved JAKAFI and OPZELURA indications use this mechanism. | — | 2028-12-12 | — |
| 10758543 | 2031-05-20 | DP — | — | — | — | — | — | — |
| 10869870 | 2031-05-20 | U U-3404 | — | — | — | — | — | — |
| 10869870 | 2031-05-20 | U U-3229 | — | — | — | — | — | — |
| 11219624 | 2031-05-20 | DP/U U-3229 | — | — | — | — | — | — |
| 11571425 | 2031-05-20 | DP — | — | — | — | — | — | — |
| 11571425 | 2031-05-20 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | — | — |
| 11590136 | 2031-05-20 | U U-3404 | — | — | — | — | — | — |
| 11590136 | 2031-05-20 | U U-3229 | — | — | — | — | — | — |
| 11590136 | 2031-05-20 | ORANGE_BOOK U-3229,U-3404 | N | Y | DS_EQUIVALENT Independent claims 1 and 22 cover 0.5-1.5% or about 1.5% topical ruxolitinib treatment of skin disorders; both AD and vitiligo are covered. The exact approved cream supplies the skin-permeation means described in the specification. GNR whole-label DS-equivalent; not a finding that every alternative generic formulation infringes. Claims 16/10 at 1.0%/0.5% are not the basis for the 1.5% product. | — | — | — |
| 12226419 | 2031-05-20 | DP — | — | — | — | — | — | — |
| 12226419 | 2031-05-20 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | — | — |
| 12544381 | 2031-05-20 | DP — | — | — | — | — | — | — |
| 12544381 | 2031-05-20 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | — | — |
| 12564593 | 2031-05-20 | DP — | — | — | — | — | — | — |
| 12564593 | 2031-05-20 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | — | — |
| 10758543 | 2031-11-20 | — — | — | — | — | — | 2031-11-20 | — |
| 10758543 | 2031-11-20 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2031-11-20 | — |
| 10869870 | 2031-11-20 | — — | — | — | — | — | 2031-11-20 | — |
| 10869870 | 2031-11-20 | ORANGE_BOOK U-3229,U-3404 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2031-11-20 | — |
| 11219624 | 2031-11-20 | — — | — | — | — | — | 2031-11-20 | — |
| 11219624 | 2031-11-20 | ORANGE_BOOK U-3229 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2031-11-20 | — |
| 11590138 | 2040-06-10 | U U-3551 | — | — | — | — | — | — |
| 11590138 | 2040-06-10 | ORANGE_BOOK U-3551 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 12233067 | 2040-07-28 | U U-4151 | — | — | — | — | — | — |
| 12233067 | 2040-07-28 | ORANGE_BOOK U-4151 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 11510923 | 2040-09-04 | U U-3505 | — | — | — | — | — | — |
| 11510923 | 2040-09-04 | ORANGE_BOOK U-3505 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 11590137 | 2040-09-04 | U U-3505 | — | — | — | — | — | — |
| 11590137 | 2040-09-04 | ORANGE_BOOK U-3505 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 12589096 | 2040-09-04 | U U-3505 | — | — | — | — | — | — |
| 12589096 | 2040-09-04 | ORANGE_BOOK U-3505 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 11602536 | 2041-05-05 | U U-3550 | — | — | — | — | — | — |
| 11602536 | 2041-05-05 | ORANGE_BOOK U-3550 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-896 | — | 2025-07-18 | — | — | — | — | Source | |
| I-896 | — | 2025-07-18 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| PED | — | 2026-01-18 | — | — | — | — | Source | |
| PED | — | 2026-01-18 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| NPP | — | 2028-09-18 | — | — | — | — | Source | |
| NPP | — | 2028-09-18 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | 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 (23)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-06-12 | HISTORICAL_CONTEXT | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2027-06-12 | HISTORICAL_CONTEXT | Independent claims 1/3: ruxolitinib JAK1/JAK2 inhibition or signal blocking, without indication restriction. | Source |
| PATENT | 2027-06-12 | HISTORICAL_CONTEXT | Ruxolitinib inhibition of JAK1/JAK2 in autoimmune skin disease; includes both current OPZELURA indications. | Source |
| PATENT | 2028-06-24 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2028-06-24 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2028-12-12 | HISTORICAL_CONTEXT | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2028-12-12 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2028-12-12 | HISTORICAL_CONTEXT | Independent claims 1/8/15: ruxolitinib phosphate inhibition/modulation of JAK1/JAK2, no disease restriction; all approved JAKAFI and OPZELURA indications use this mechanism. | Source |
| PATENT | 2031-05-20 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2031-05-20 | CANONICAL_ANCHOR | Independent claims 1 and 22 cover 0.5-1.5% or about 1.5% topical ruxolitinib treatment of skin disorders; both AD and vitiligo are covered. The exact approved cream supplies the skin-permeation means described in the specification. GNR whole-label DS-equivalent; not a finding that every alternative generic formulation infringes. Claims 16/10 at 1.0%/0.5% are not the basis for the 1.5% product. | Source |
| PATENT | 2031-05-20 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2031-05-20 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2031-05-20 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2031-11-20 | FTO_TAIL | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2031-11-20 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2031-11-20 | FTO_TAIL | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2040-06-10 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2040-07-28 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2040-09-04 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2040-09-04 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2040-09-04 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| PATENT | 2041-05-05 | FTO_TAIL | Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | Source |
| REGULATORY_STATUS | 2031-05-20 | CANONICAL_DECISION | English description not available. | 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.