Product profile · United States
LUZU
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Latest qualifying historical full-scope anchor 2020-01-18; 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 |
|---|---|---|---|---|---|---|---|---|
| US5900488 | 2020-01-18 | DS/DP — | Y | N | TRUE_DS Claim 1 claims luliconazole itself, without crystal/formulation/use limitations. Claim 4 additionally addresses mycoses. Latest historical FDA-listed end is 2020-01-18; earlier listings 2016-07-05 and 2017-07-05 are preserved. Google assumed end 2020-01-17 is not substituted for the FDA-listed date. | — | — | — |
| 9012484 | 2033-09-06 | DS/DP/U U-540 | N | N | OTHER | — | — | — |
| 9012484 | 2033-09-06 | DS/DP/U U-540 | N | N | OTHER Claim 1 requires a luliconazole crystal composite containing 100-10000 ppm short-chain alcohol and specified lattice parameters. Substance listing flag does not establish a broad molecule claim. | — | — | — |
| 9199977 | 2033-09-06 | DS/DP — | N | N | OTHER | — | — | — |
| 9199977 | 2033-09-06 | DS/DP — | N | N | OTHER Claim 1 requires alcohol recrystallization and a specific (021) growth plane. Crystal-habit limitation; not broad molecule protection. | — | — | — |
| 9453006 | 2033-09-06 | DS — | N | N | OTHER | — | — | — |
| 9453006 | 2033-09-06 | DS — | N | N | OTHER Claim 1 requires alcohol recrystallization and a specific (011) growth plane. Crystal-habit limitation; not broad molecule protection. | — | — | — |
| 8980931 | 2034-04-28 | DP — | N | N | DP | — | — | — |
| 8980931 | 2034-04-28 | DP — | N | N | DP Claims require polyhydric alcohol/ether, dibasic ester and limited degradation products. Formulation rather than broad luliconazole coverage. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2013-11-14 | 2018-11-14 | Active-moiety-wide regulatory exclusivity. NUMBRINO shares the cocaine NCE barrier originating with GOPRELTO; its listed NCE end is not a fresh five-year term from its 2020 approval. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2018-11-14 | Source | |
| NPP | 2018-02-20 | 2021-02-20 | Pediatric expansion: tinea pedis/cruris at age 12 or older and tinea corporis at age 2 or older. Established adult treatment remains 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 |
|---|---|---|---|---|---|---|---|
| 204153 / 001 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Bausch Health US, 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 |
|---|---|---|---|---|---|---|
| 204153 / 001 | Bausch Health US, 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 (8)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2020-01-18 | CANONICAL_ANCHOR | Claim 1 claims luliconazole itself, without crystal/formulation/use limitations. Claim 4 additionally addresses mycoses. Latest historical FDA-listed end is 2020-01-18; earlier listings 2016-07-05 and 2017-07-05 are preserved. Google assumed end 2020-01-17 is not substituted for the FDA-listed date. | Source |
| PATENT | 2033-09-06 | FTO_TAIL | Claim 1 requires alcohol recrystallization and a specific (021) growth plane. Crystal-habit limitation; not broad molecule protection. | Source |
| PATENT | 2033-09-06 | FTO_TAIL | Claim 1 requires alcohol recrystallization and a specific (011) growth plane. Crystal-habit limitation; not broad molecule protection. | Source |
| PATENT | 2033-09-06 | FTO_TAIL | Claim 1 requires a luliconazole crystal composite containing 100-10000 ppm short-chain alcohol and specified lattice parameters. Substance listing flag does not establish a broad molecule claim. | Source |
| PATENT | 2034-04-28 | FTO_TAIL | Claims require polyhydric alcohol/ether, dibasic ester and limited degradation products. Formulation rather than broad luliconazole coverage. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Pediatric expansion: tinea pedis/cruris at age 12 or older and tinea corporis at age 2 or older. Established adult treatment remains outside new-population exclusivity. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | 2018-11-14 | CANONICAL_ANCHOR | Active-moiety-wide regulatory exclusivity. NUMBRINO shares the cocaine NCE barrier originating with GOPRELTO; its listed NCE end is not a fresh five-year term from its 2020 approval. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_STATUS | 2020-01-18 | DECISION_BASIS | Latest qualifying historical full-scope anchor 2020-01-18; later patent/regulatory rights remain, so 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.