SORILUX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Latest qualifying historical full-scope anchor 2013-10-06; later patent/regulatory rights remain, so DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8629128 | 2026-05-26 | DP/U U-1767 | N | N | DP | — | — | — |
| 8629128 | 2026-05-26 | DP/U U-2662 | N | N | DP | — | — | — |
| 8629128 | 2026-05-26 | DP/U U-1280 | N | N | DP | — | — | — |
| 8629128 | 2026-05-26 | DP/U U-1280,U-1767,U-2662 | N | N | DP Calcipotriene foam claims require water/oil phases, stabilizer, emulsifier, occlusive agent, solvent and propellant. DP. | — | — | — |
| 8263580 | 2028-05-07 | DP/U U-1280 | N | N | DP | — | — | — |
| 8263580 | 2028-05-07 | DP/U U-2662 | N | N | DP | — | — | — |
| 8263580 | 2028-05-07 | DP/U U-1280,U-2662 | N | N | DP Vitamin-D analogue oil-in-water aerosol foam claims require phase, stabilizer, solvent and emulsifier features. Formulation-dependent psoriasis use does not automatically create a DS-equivalent anchor. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NDF | 2010-10-06 | 2013-10-06 | Original calcipotriene foam scope for adult plaque psoriasis of the body. Scalp use was added later and pediatric use was added in 2019. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2013-10-06 | Source | |
| I-657 | 2012-09-27 | 2015-09-27 | Plaque psoriasis of the scalp. Body use is outside this separate indication right. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| NPP | 2019-05-06 | 2022-05-06 | Pediatric expansion to age 12 or older (2019-05-06) or age 4 or older (2019-11-05), respectively. Adult scalp/body use is outside new-population exclusivity. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| NPP | 2019-11-05 | 2022-11-05 | Pediatric expansion to age 12 or older (2019-05-06) or age 4 or older (2019-11-05), respectively. Adult scalp/body use is outside new-population exclusivity. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_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 |
|---|---|---|---|---|---|---|---|
| 022563 / 001 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Mayne Pharma LLC | Y | 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 1 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 022563 / 001 | Mayne Pharma LLC | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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 (7)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-05-26 | FTO_TAIL | Calcipotriene foam claims require water/oil phases, stabilizer, emulsifier, occlusive agent, solvent and propellant. DP. | Source |
| PATENT | 2028-05-07 | FTO_TAIL | Vitamin-D analogue oil-in-water aerosol foam claims require phase, stabilizer, solvent and emulsifier features. Formulation-dependent psoriasis use does not automatically create a DS-equivalent anchor. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Pediatric expansion to age 12 or older (2019-05-06) or age 4 or older (2019-11-05), respectively. Adult scalp/body use is outside new-population exclusivity. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Pediatric expansion to age 12 or older (2019-05-06) or age 4 or older (2019-11-05), respectively. Adult scalp/body use is outside new-population exclusivity. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Plaque psoriasis of the scalp. Body use is outside this separate indication right. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | 2013-10-06 | CANONICAL_ANCHOR | Original calcipotriene foam scope for adult plaque psoriasis of the body. Scalp use was added later and pediatric use was added in 2019. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_STATUS | 2013-10-06 | DECISION_BASIS | Latest qualifying historical full-scope anchor 2013-10-06; later patent/regulatory rights remain, so DEEP_REVIEW. | 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.