Product profile · United States
INGREZZA SPRINKLE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Patents remain through 2040 after the verified compound TRUE_DS expiry; adopt DEEP_REVIEW. Recognizing quality-characteristic claims as DS-equivalent could change the anchor.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8357697 | 2027-11-08 | U U-1995 | N | Y | DS_EQUIVALENT | — | — | — |
| 8357697 | 2027-11-08 | U U-3055 | N | Y | DS_EQUIVALENT | — | — | — |
| 8357697 | 2027-11-08 | U U-1995 | N | Y | DS_EQUIVALENT Independent claim 1 treats hyperkinetic disorders with valbenazine or permitted salt/solvate. Dependent claim 2 specifies HD/TD; no specific crystal-form, population, or dose restriction, covering both approved indications. DS-equivalent Y. Expiry 2027-11-08 precedes TRUE_DS 8039627 expiry 2031-04-11, so the final anchor is unchanged. | — | — | — |
| 8357697 | 2027-11-08 | U U-3055 | N | Y | DS_EQUIVALENT Independent claim 1 treats hyperkinetic disorders with valbenazine or permitted salt/solvate. Dependent claim 2 specifies HD/TD; no specific crystal-form, population, or dose restriction, covering both approved indications. DS-equivalent Y. Expiry 2027-11-08 precedes TRUE_DS 8039627 expiry 2031-04-11, so the final anchor is unchanged. | — | — | — |
| 8039627 | 2031-04-11 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8039627 | 2031-04-11 | DS/DP — | Y | Y | TRUE_DS Claim 1: valbenazine compound or pharmaceutically acceptable salt; claim 2: composition. | — | — | — |
| 10065952 | 2036-10-28 | DS/DP/U U-1995 | N | N | CRYSTALLINE_FORM | — | — | — |
| 10065952 | 2036-10-28 | DS/DP/U U-3055 | N | N | CRYSTALLINE_FORM | — | — | — |
| 10065952 | 2036-10-28 | DS/DP/U U-1995 | N | N | CRYSTALLINE_FORM Independent claims 1-9: specific crystal/amorphous forms defined by XRPD. Treatment claims 13/17 also depend on the claim 1 crystal form. N/N despite official DS=Y. | — | — | — |
| 10065952 | 2036-10-28 | DS/DP/U U-3055 | N | N | CRYSTALLINE_FORM Independent claims 1-9: specific crystal/amorphous forms defined by XRPD. Treatment claims 13/17 also depend on the claim 1 crystal form. N/N despite official DS=Y. | — | — | — |
| 10844058 | 2036-10-28 | DS/DP/U U-1995 | N | N | CRYSTALLINE_FORM | — | — | — |
| 10844058 | 2036-10-28 | DS/DP/U U-3055 | N | N | CRYSTALLINE_FORM | — | — | — |
| 10844058 | 2036-10-28 | DS/DP/U U-3055 | N | N | CRYSTALLINE_FORM Independent claim 1: valbenazine tosylate crystal form with DSC peak 243 C +/-2%; treatment claim 26 depends on that form. N/N. | — | — | — |
| 10844058 | 2036-10-28 | DS/DP/U U-1995 | N | N | CRYSTALLINE_FORM Independent claim 1: valbenazine tosylate crystal form with DSC peak 243 C +/-2%; treatment claim 26 depends on that form. N/N. | — | — | — |
| 10851103 | 2036-10-28 | DS/DP/U U-1995 | N | N | CRYSTALLINE_FORM | — | — | — |
| 10851103 | 2036-10-28 | DS/DP/U U-3055 | N | N | CRYSTALLINE_FORM | — | — | — |
| 10851103 | 2036-10-28 | DS/DP/U U-3055 | N | N | CRYSTALLINE_FORM Independent claim 1: valbenazine tosylate crystal form with DSC onset 240 C +/-2%; treatment claim 26 depends on that form. N/N. | — | — | — |
| 10851103 | 2036-10-28 | DS/DP/U U-1995 | N | N | CRYSTALLINE_FORM Independent claim 1: valbenazine tosylate crystal form with DSC onset 240 C +/-2%; treatment claim 26 depends on that form. N/N. | — | — | — |
| 10851104 | 2036-10-28 | DS/U U-1995 | N | N | CRYSTALLIZATION_PROCESS | — | — | — |
| 10851104 | 2036-10-28 | DS/U U-3055 | N | N | CRYSTALLIZATION_PROCESS | — | — | — |
| 10851104 | 2036-10-28 | DS/U U-1995 | N | N | CRYSTALLIZATION_PROCESS Valbenazine tosylate Form I crystallization process. | — | — | — |
| 10851104 | 2036-10-28 | DS/U U-3055 | N | N | CRYSTALLIZATION_PROCESS Valbenazine tosylate Form I crystallization process. | — | — | — |
| 10906902 | 2036-12-22 | DS/DP — | N | N | PRODUCT_BY_PROCESS | — | — | — |
| 10906902 | 2036-12-22 | DS/DP — | N | N | PRODUCT_BY_PROCESS Claim 1: VMAT2 inhibitor manufactured by a specified salt-conversion process. | — | — | — |
| 10906903 | 2036-12-22 | DS/DP — | N | N | QUALITY_ATTRIBUTE_COMPOUND | — | — | — |
| 10906903 | 2036-12-22 | DS/DP — | N | N | QUALITY_ATTRIBUTE_COMPOUND Claim 1: valbenazine limited to loss on drying <=5%. DS-equivalent adopted classification finalized; rereview default N, with the adopted classification basis retained. | — | — | — |
| 10919892 | 2036-12-22 | DS/DP — | N | N | QUALITY_ATTRIBUTE_COMPOUND | — | — | — |
| 10919892 | 2036-12-22 | DS/DP — | N | N | QUALITY_ATTRIBUTE_COMPOUND Claim 1: valbenazine limited to total impurities <=5%. DS-equivalent adopted classification finalized; rereview default N, with the adopted classification basis retained. | — | — | — |
| 10857137 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10857137 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD CYP2D6 poor metabolizer40mg·genotype/dose adjustment | — | — | — |
| 10857148 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10857148 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD with concomitant digoxin, monitoring, and digoxin dose reduction. | — | — | — |
| 10874648 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10874648 | 2037-10-10 | U U-3055 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10874648 | 2037-10-10 | U U-3046 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10874648 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Patient population receiving a VMAT2 inhibitor after discontinuing a strong CYP3A4 inducer. | — | — | — |
| 10874648 | 2037-10-10 | U U-3046 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Patient population receiving a VMAT2 inhibitor after discontinuing a strong CYP3A4 inducer. | — | — | — |
| 10874648 | 2037-10-10 | U U-3055 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Patient population receiving a VMAT2 inhibitor after discontinuing a strong CYP3A4 inducer. | — | — | — |
| 10912771 | 2037-10-10 | U U-3076 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10912771 | 2037-10-10 | U U-3055 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10912771 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10912771 | 2037-10-10 | U U-3055 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Patient population receiving valbenazine after discontinuing a strong CYP3A4 inducer. | — | — | — |
| 10912771 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Patient population receiving valbenazine after discontinuing a strong CYP3A4 inducer. | — | — | — |
| 10912771 | 2037-10-10 | U U-3076 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Patient population receiving valbenazine after discontinuing a strong CYP3A4 inducer. | — | — | — |
| 10952997 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10952997 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD with concomitant strong CYP3A4 inhibitor and 40 mg/dose adjustment. | — | — | — |
| 10993941 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10993941 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD with moderate/severe hepatic impairment, 40 mg, and hepatic classification. | — | — | — |
| 11040029 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11040029 | 2037-10-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD with concomitant strong CYP2D6 inhibitor and 40 mg/dose adjustment. | — | — | — |
| 11439629 | 2037-10-10 | U U-3055 | N | N | POPULATION_DOSE_RESTRICTED_USE | — | — | — |
| 11439629 | 2037-10-10 | U U-3055 | N | N | POPULATION_DOSE_RESTRICTED_USE Independent claim 1: CYP2D6 poor metabolizer, chorea, and 40 mg once daily. Does not cover all TD/HD populations and strengths; N/N. | — | — | — |
| 11026939 | 2038-09-18 | DP/U U-3055 | N | N | FORMULATION | — | — | — |
| 11026939 | 2038-09-18 | DP/U U-1995 | N | N | FORMULATION | — | — | — |
| 11026939 | 2038-09-18 | DP/U U-3055 | N | N | FORMULATION Independent claim 1: valbenazine ditosylate 20-160 mg, API >=30% w/w, and fixed silicified MCC/isomalt/HPMC/starch/Mg stearate excipients. N/N. | — | — | — |
| 11026939 | 2038-09-18 | DP/U U-1995 | N | N | FORMULATION Independent claim 1: valbenazine ditosylate 20-160 mg, API >=30% w/w, and fixed silicified MCC/isomalt/HPMC/starch/Mg stearate excipients. N/N. | — | — | — |
| 11311532 | 2038-09-18 | DP/U U-1995 | N | N | FORMULATION | — | — | — |
| 11311532 | 2038-09-18 | DP/U U-3055 | N | N | FORMULATION | — | — | — |
| 11311532 | 2038-09-18 | DP/U U-1995 | N | N | FORMULATION Independent claim 1: valbenazine ditosylate >=30% w/w with insoluble filler, water-soluble diluent, binder, disintegrant, and lubricant. Formulation-limited; N/N. | — | — | — |
| 11311532 | 2038-09-18 | DP/U U-3055 | N | N | FORMULATION Independent claim 1: valbenazine ditosylate >=30% w/w with insoluble filler, water-soluble diluent, binder, disintegrant, and lubricant. Formulation-limited; N/N. | — | — | — |
| 11654142 | 2038-11-14 | U U-3055 | N | N | INDICATION_COADMINISTRATION_RESTRICTED_USE | — | — | — |
| 11654142 | 2038-11-14 | U U-3055 | N | N | INDICATION_COADMINISTRATION_RESTRICTED_USE Independent claim 1 administers a VMAT2 inhibitor to Huntington-disease chorea patients taking digoxin, monitors blood digoxin, and reduces digoxin dose if exposure increases. Claims 2-15 are dependent. Excludes TD and patients not taking digoxin: DS-equivalent N. Verified corrections to claims 8/10/12/13/14 in the USPTO certificate of correction. | — | — | — |
| 11026931 | 2039-08-14 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11026931 | 2039-08-14 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD hypersensitivity monitoring/discontinuation or 40-to-80 mg titration; excludes HD. | — | — | — |
| 10940141 | 2040-08-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10940141 | 2040-08-10 | U U-1995 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE TD with severe renal impairment and continuation of the normal dose; excludes HD. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-925 | 2023-08-18 | 2026-08-18 | Adult chorea associated with Huntington disease; does not cover tardive dyskinesia. | N | N | — | Source | |
| I-925 | 2023-08-18 | 2026-08-18 | Adult chorea associated with Huntington disease; does not cover tardive dyskinesia. | N | N | — | Source |
2026-10-10 · CURRENT_SNAPSHOT_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 216064 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2024-04-05 | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216137 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-07 | — | ZYDUS LIFESCIENCES GLOBAL FZE | N | 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 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 |
|---|---|---|---|---|---|---|
| 216064 / 002 | LUPIN LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-04-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216137 / 003 | ZYDUS LIFESCIENCES GLOBAL FZE | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (34)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-11-08 | LISTING_CONTEXT | Independent claim 1 treats hyperkinetic disorders with valbenazine or permitted salt/solvate. Dependent claim 2 specifies HD/TD; no specific crystal-form, population, or dose restriction, covering both approved indications. DS-equivalent Y. Expiry 2027-11-08 precedes TRUE_DS 8039627 expiry 2031-04-11, so the final anchor is unchanged. | Source |
| PATENT | 2027-11-08 | LISTING_CONTEXT | Independent claim 1 treats hyperkinetic disorders with valbenazine or permitted salt/solvate. Dependent claim 2 specifies HD/TD; no specific crystal-form, population, or dose restriction, covering both approved indications. DS-equivalent Y. Expiry 2027-11-08 precedes TRUE_DS 8039627 expiry 2031-04-11, so the final anchor is unchanged. | Source |
| PATENT | 2031-04-11 | CANONICAL_ANCHOR | Claim 1: valbenazine compound or pharmaceutically acceptable salt; claim 2: composition. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Independent claims 1-9: specific crystal/amorphous forms defined by XRPD. Treatment claims 13/17 also depend on the claim 1 crystal form. N/N despite official DS=Y. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Independent claim 1: valbenazine tosylate crystal form with DSC peak 243 C +/-2%; treatment claim 26 depends on that form. N/N. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Independent claim 1: valbenazine tosylate crystal form with DSC onset 240 C +/-2%; treatment claim 26 depends on that form. N/N. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Valbenazine tosylate Form I crystallization process. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Valbenazine tosylate Form I crystallization process. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Independent claim 1: valbenazine tosylate crystal form with DSC onset 240 C +/-2%; treatment claim 26 depends on that form. N/N. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Independent claim 1: valbenazine tosylate crystal form with DSC peak 243 C +/-2%; treatment claim 26 depends on that form. N/N. | Source |
| PATENT | 2036-10-28 | FTO_TAIL | Independent claims 1-9: specific crystal/amorphous forms defined by XRPD. Treatment claims 13/17 also depend on the claim 1 crystal form. N/N despite official DS=Y. | Source |
| PATENT | 2036-12-22 | FTO_TAIL | Claim 1: valbenazine limited to total impurities <=5%. DS-equivalent adopted classification finalized; rereview default N, with the adopted classification basis retained. | Source |
| PATENT | 2036-12-22 | FTO_TAIL | Claim 1: valbenazine limited to loss on drying <=5%. DS-equivalent adopted classification finalized; rereview default N, with the adopted classification basis retained. | Source |
| PATENT | 2036-12-22 | FTO_TAIL | Claim 1: VMAT2 inhibitor manufactured by a specified salt-conversion process. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Patient population receiving a VMAT2 inhibitor after discontinuing a strong CYP3A4 inducer. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Patient population receiving valbenazine after discontinuing a strong CYP3A4 inducer. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Patient population receiving a VMAT2 inhibitor after discontinuing a strong CYP3A4 inducer. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | TD with concomitant digoxin, monitoring, and digoxin dose reduction. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Patient population receiving valbenazine after discontinuing a strong CYP3A4 inducer. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | TD with concomitant strong CYP3A4 inhibitor and 40 mg/dose adjustment. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Patient population receiving valbenazine after discontinuing a strong CYP3A4 inducer. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | TD CYP2D6 poor metabolizer40mg·genotype/dose adjustment | Source |
| PATENT | 2037-10-10 | FTO_TAIL | TD with moderate/severe hepatic impairment, 40 mg, and hepatic classification. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Patient population receiving a VMAT2 inhibitor after discontinuing a strong CYP3A4 inducer. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | TD with concomitant strong CYP2D6 inhibitor and 40 mg/dose adjustment. | Source |
| PATENT | 2037-10-10 | FTO_TAIL | Independent claim 1: CYP2D6 poor metabolizer, chorea, and 40 mg once daily. Does not cover all TD/HD populations and strengths; N/N. | Source |
| PATENT | 2038-09-18 | FTO_TAIL | Independent claim 1: valbenazine ditosylate 20-160 mg, API >=30% w/w, and fixed silicified MCC/isomalt/HPMC/starch/Mg stearate excipients. N/N. | Source |
| PATENT | 2038-09-18 | FTO_TAIL | Independent claim 1: valbenazine ditosylate >=30% w/w with insoluble filler, water-soluble diluent, binder, disintegrant, and lubricant. Formulation-limited; N/N. | Source |
| PATENT | 2038-09-18 | FTO_TAIL | Independent claim 1: valbenazine ditosylate >=30% w/w with insoluble filler, water-soluble diluent, binder, disintegrant, and lubricant. Formulation-limited; N/N. | Source |
| PATENT | 2038-09-18 | FTO_TAIL | Independent claim 1: valbenazine ditosylate 20-160 mg, API >=30% w/w, and fixed silicified MCC/isomalt/HPMC/starch/Mg stearate excipients. N/N. | Source |
| PATENT | 2038-11-14 | FTO_TAIL | Independent claim 1 administers a VMAT2 inhibitor to Huntington-disease chorea patients taking digoxin, monitors blood digoxin, and reduces digoxin dose if exposure increases. Claims 2-15 are dependent. Excludes TD and patients not taking digoxin: DS-equivalent N. Verified corrections to claims 8/10/12/13/14 in the USPTO certificate of correction. | Source |
| PATENT | 2039-08-14 | FTO_TAIL | TD hypersensitivity monitoring/discontinuation or 40-to-80 mg titration; excludes HD. | Source |
| PATENT | 2040-08-10 | FTO_TAIL | TD with severe renal impairment and continuation of the normal dose; excludes HD. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Adult chorea associated with Huntington disease; does not cover tardive dyskinesia. | 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.