Product profile · United States
LIPTRUZET
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
DATED_FDA_RECORDED_MANUFACTURER_DISCONTINUATION_NOTIFICATION; canonical 2014 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. FDA-recorded manufacturer notification date; not certified last-sales day.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5846966 | 2014-03-21 | DP/U/PED U-1400 | N | Y | DS_EQUIVALENT Independent method claim6 administers the ezetimibe azetidinone class with an HMG-CoA reductase inhibitor to reduce plasma cholesterol; claims8/10 identify atorvastatin and ezetimibe. LIPTRUZET approved primary hyperlipidemia and homozygous familial hypercholesterolemia uses both seek cholesterol/LDL reduction. No fixed excipient or strength limitation in the broad method. Classification remains DS_EQUIVALENT after 2024 label comparison: independent claim1 broadly protects the azetidinone/statin combination composition for atherosclerosis prevention/treatment or cholesterol reduction; claims3/5 expressly include atorvastatin and ezetimibe. Independent method claim6 also includes atherosclerosis prevention/treatment. Thus the basis is not limited to a cholesterol-only method. No mandatory XRPD or specific excipient restriction is imposed. | — | 2014-03-21 | — |
| US5686104 | 2015-05-11 | DP/U/PED U-1400 | N | N | DP Atorvastatin formulation with alkaline stabilizer plus quantitative binder, diluent, disintegrant, surfactant and lubricant limitations; process claims remain formulation-specific. | — | 2015-05-11 | — |
| US5969156 | 2017-01-08 | DS/PED — | N | N | DP_SOLID_STATE Independent claims protect crystalline FormI atorvastatin hydrate defined by XRPD/NMR signatures; other independent claims address further solid forms/processes. Not broad atorvastatin regardless of solid state. | — | 2017-01-08 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NC | 2013-05-03 | 2016-05-03 | FULL_HISTORICAL_ORIGINAL_COMBINATION_SCOPE; NC through 2016-05-03 covers the original exact ezetimibe/atorvastatin combination for primary hyperlipidemia and HoFH. The October 2024 label now separately states cardiovascular risk-reduction uses for the atorvastatin component. This was not a demonstrated new combination cardiovascular benefit; nevertheless, the old NC studies do not establish protection of every current label use. Preserve full original-scope history and do not promote it as a complete 2024-label anchor. This later scope distinction must be reconciled in the subsequent final patent/exclusivity judgment. | 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 |
|---|---|---|---|---|---|---|---|
| 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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2014-03-21 | CANONICAL_ANCHOR | Independent method claim6 administers the ezetimibe azetidinone class with an HMG-CoA reductase inhibitor to reduce plasma cholesterol; claims8/10 identify atorvastatin and ezetimibe. LIPTRUZET approved primary hyperlipidemia and homozygous familial hypercholesterolemia uses both seek cholesterol/LDL reduction. No fixed excipient or strength limitation in the broad method. Classification remains DS_EQUIVALENT after 2024 label comparison: independent claim1 broadly protects the azetidinone/statin combination composition for atherosclerosis prevention/treatment or cholesterol reduction; claims3/5 expressly include atorvastatin and ezetimibe. Independent method claim6 also includes atherosclerosis prevention/treatment. Thus the basis is not limited to a cholesterol-only method. No mandatory XRPD or specific excipient restriction is imposed. | Source |
| PATENT | 2015-05-11 | FTO_TAIL | Atorvastatin formulation with alkaline stabilizer plus quantitative binder, diluent, disintegrant, surfactant and lubricant limitations; process claims remain formulation-specific. | Source |
| PATENT | 2017-01-08 | FTO_TAIL | Independent claims protect crystalline FormI atorvastatin hydrate defined by XRPD/NMR signatures; other independent claims address further solid forms/processes. Not broad atorvastatin regardless of solid state. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | FULL_HISTORICAL_ORIGINAL_COMBINATION_SCOPE; NC through 2016-05-03 covers the original exact ezetimibe/atorvastatin combination for primary hyperlipidemia and HoFH. The October 2024 label now separately states cardiovascular risk-reduction uses for the atorvastatin component. This was not a demonstrated new combination cardiovascular benefit; nevertheless, the old NC studies do not establish protection of every current label use. Preserve full original-scope history and do not promote it as a complete 2024-label anchor. This later scope distinction must be reconciled in the subsequent final patent/exclusivity judgment. | Source |
| REGULATORY_STATUS | 2015-06-01 | TERMINAL_STATUS | DATED_FDA_RECORDED_MANUFACTURER_DISCONTINUATION_NOTIFICATION; canonical 2014 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. FDA-recorded manufacturer notification date; not certified last-sales day. | 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.