Product profile · United States
EUCRISA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Exact-product FDA Final ANDA approval and AB/RLD mapping verified; Authorized Generic and Tentative Approval excluded.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8501712 | 2027-02-16 | U U-1932 | N | Y | DS_EQUIVALENT | — | — | — |
| 9682092 | 2027-02-16 | U U-1932 | N | Y | DS_EQUIVALENT | — | — | — |
| 8501712 | 2027-08-16 | — — | N | Y | DS_EQUIVALENT | — | 2027-08-16 | — |
| 8501712 | 2027-08-16 | U/PED U-1932 | N | Y | DS_EQUIVALENT Claims 1 and 7-9 encompass dermatitis, eczema and atopic dermatitis without an indication carve-out for EUCRISA. DS_EQUIVALENT. | — | 2027-08-16 | — |
| 9682092 | 2027-08-16 | — — | N | Y | DS_EQUIVALENT | — | 2027-08-16 | — |
| 9682092 | 2027-08-16 | U/PED U-1932 | N | Y | DS_EQUIVALENT Boron-compound anti-inflammatory treatment claims encompass the crisaborole atopic-dermatitis use. DS_EQUIVALENT. | — | 2027-08-16 | — |
| 8039451 | 2029-06-29 | DS/DP — | Y | N | TRUE_DS | — | — | — |
| 8039451 | 2029-12-29 | — — | Y | N | TRUE_DS | — | 2029-12-29 | — |
| 8039451 | 2029-12-29 | DS/DP/PED — | Y | N | TRUE_DS Claims 1 and 3 identify crisaborole itself; no crystal or excipient limitation. TRUE_DS. | — | 2029-12-29 | — |
| 8168614 | 2030-01-20 | U U-1932 | N | Y | DS_EQUIVALENT | — | — | — |
| 8168614 | 2030-07-20 | — — | N | Y | DS_EQUIVALENT | — | 2030-07-20 | — |
| 8168614 | 2030-07-20 | U/PED U-1932 | N | Y | DS_EQUIVALENT Broad anti-inflammatory treatment claims encompass atopic dermatitis; all approved EUCRISA use is atopic dermatitis. DS_EQUIVALENT for this product. | — | 2030-07-20 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2016-12-14 | 2021-12-14 | 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 | 2021-12-14 | Source | |
| PED | — | 2022-06-14 | Attached six-month extension; underlying regulatory exclusivity retained separately. Not an independent grant. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2022-06-14 | Source | |
| NPP | 2020-03-23 | 2023-03-23 | Expansion of atopic dermatitis treatment to patients aged 3 months to less than 2 years. Existing older-patient use remains outside the new-population scope. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| PED | — | 2023-09-23 | Attached six-month extension; underlying regulatory exclusivity retained separately. Not an independent grant. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| D-191 | 2023-04-03 | 2026-04-03 | Additional once-daily maintenance dosing for atopic dermatitis. Existing twice-daily treatment remains outside this dosing right; all disease-indication language does not establish all-regimen coverage. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| D-191 | 2023-04-03 | 2026-04-03 | Additional once-daily maintenance dosing for atopic dermatitis. Existing twice-daily treatment remains outside this dosing right; all disease-indication language does not establish all-regimen coverage. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source |
2026-10-12 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| 216242 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | MACLEODS PHARMS | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 216242 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | MACLEODS PHARMS | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 216242 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | — | MACLEODS PHARMS | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 216242 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | — | MACLEODS PHARMS | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | 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 |
|---|---|---|---|---|---|---|
| 216242 / 001 | MACLEODS PHARMS | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 216242 / 001 | MACLEODS PHARMS | FINAL_APPROVAL · FINAL_APPROVAL | 2026-09-24 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (11)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2026-09-24 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA216242/001 -> NDA207695/001 | Source |
| PATENT | 2027-08-16 | LISTING_CONTEXT | Claims 1 and 7-9 encompass dermatitis, eczema and atopic dermatitis without an indication carve-out for EUCRISA. DS_EQUIVALENT. | Source |
| PATENT | 2027-08-16 | LISTING_CONTEXT | Boron-compound anti-inflammatory treatment claims encompass the crisaborole atopic-dermatitis use. DS_EQUIVALENT. | Source |
| PATENT | 2029-12-29 | LISTING_CONTEXT | Claims 1 and 3 identify crisaborole itself; no crystal or excipient limitation. TRUE_DS. | Source |
| PATENT | 2030-07-20 | CANONICAL_ANCHOR | Broad anti-inflammatory treatment claims encompass atopic dermatitis; all approved EUCRISA use is atopic dermatitis. DS_EQUIVALENT for this product. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Additional once-daily maintenance dosing for atopic dermatitis. Existing twice-daily treatment remains outside this dosing right; all disease-indication language does not establish all-regimen coverage. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Attached six-month extension; underlying regulatory exclusivity retained separately. Not an independent grant. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Expansion of atopic dermatitis treatment to patients aged 3 months to less than 2 years. Existing older-patient use remains outside the new-population scope. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | 2021-12-14 | SCOPE_CONTEXT | 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_EXCLUSIVITY | 2022-06-14 | SCOPE_CONTEXT | Attached six-month extension; underlying regulatory exclusivity retained separately. Not an independent grant. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_STATUS | 2026-09-24 | DECISION_BASIS | Exact-product FDA Final ANDA approval and AB/RLD mapping verified; Authorized Generic and Tentative Approval excluded. | 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.