Product profile · United States
INVOKAMET
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7943788 | 2027-07-14 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 7943788 | 2027-07-14 | DS/DP — | Y | Y | TRUE_DS Compound genus and independent claim 12 explicitly name canagliflozin or acceptable salt; no crystal/formulation restriction. | — | — | — |
| 8513202 | 2027-12-03 | DS/DP/U U-493 | N | N | CRYSTAL_USE | — | — | — |
| 8513202 | 2027-12-03 | DS/DP/U U-2441 | N | N | CRYSTAL_USE | — | — | — |
| 8513202 | 2027-12-03 | DS/DP/U U-2632 | N | N | CRYSTAL_USE | — | — | — |
| 8513202 | 2027-12-03 | DS/DP/U U-2441 | N | N | CRYSTAL_USE Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | — | — | — |
| 8513202 | 2027-12-03 | DS/DP/U U-493 | N | N | CRYSTAL_USE Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | — | — | — |
| 8513202 | 2027-12-03 | DS/DP/U U-2632 | N | N | CRYSTAL_USE Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | — | — | — |
| 7943788 | 2028-01-14 | — — | Y | Y | TRUE_DS | — | 2028-01-14 | — |
| 7943788 | 2028-01-14 | PED — | Y | Y | TRUE_DS Compound genus and independent claim 12 explicitly name canagliflozin or acceptable salt; no crystal/formulation restriction. | — | — | — |
| 8513202 | 2028-06-03 | — — | N | N | CRYSTAL_USE | — | 2028-06-03 | — |
| 8513202 | 2028-06-03 | PED — | N | N | CRYSTAL_USE Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | — | — | — |
| 7943582 | 2029-02-26 | DS/DP/U U-493 | N | N | CRYSTAL | — | — | — |
| 7943582 | 2029-02-26 | DS/DP/U U-2441 | N | N | CRYSTAL | — | — | — |
| 7943582 | 2029-02-26 | DS/DP/U U-2632 | N | N | CRYSTAL | — | — | — |
| 7943582 | 2029-02-26 | DS/DP/U U-493 | N | N | CRYSTAL Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | — | — | — |
| 7943582 | 2029-02-26 | DS/DP/U U-2441 | N | N | CRYSTAL Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | — | — | — |
| 7943582 | 2029-02-26 | DS/DP/U U-2632 | N | N | CRYSTAL Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | — | — | — |
| 7943582 | 2029-08-26 | — — | N | N | CRYSTAL | — | 2029-08-26 | — |
| 7943582 | 2029-08-26 | PED — | N | N | CRYSTAL Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | — | — | — |
| 11576894 | 2030-07-06 | DP — | N | N | FORMULATION | — | — | — |
| 11576894 | 2030-07-06 | DP — | N | N | FORMULATION Canagliflozin/metformin formulation with fixed excipient percentage ranges. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NC | 2014-08-08 | 2017-08-08 | NEW COMBINATION | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| NCE | 2013-03-29 | 2018-03-29 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2018-03-29 | I-735 + I-788 + NPP + PED
Full coverage date: 2018-03-29
| Source |
| I-735 | 2016-05-20 | 2019-05-20 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH CANAGLIFLOZIN AND METFORMIN IS APPROPRIATE | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| M-197 | 2017-02-01 | 2020-02-01 | NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| I-788 | 2018-10-29 | 2021-10-29 | NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD) | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| NPP | 2024-12-18 | 2027-12-18 | Glycemic control in pediatric patients aged 10 years and older with T2D; adult glycemic and adult cardiovascular/diabetic-nephropathy benefits remain outside this population protection. | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| NPP | 2024-12-18 | 2027-12-18 | Glycemic control in pediatric patients aged 10 years and older with T2D; adult glycemic and adult cardiovascular/diabetic-nephropathy benefits remain outside this population protection. | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| PED | 2027-12-18 | 2028-06-18 | Six-month extension of NPP: Glycemic control in pediatric patients aged 10 years and older with T2D; adult glycemic and adult cardiovascular/diabetic-nephropathy benefits remain outside this population protection. | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
| PED | 2027-12-18 | 2028-06-18 | Six-month extension of NPP: Glycemic control in pediatric patients aged 10 years and older with T2D; adult glycemic and adult cardiovascular/diabetic-nephropathy benefits remain outside this population protection. | N | N | — | I-735 + I-788 + NPP + PED
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_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 |
|---|---|---|---|---|---|---|---|
| 210542 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ZYDUS PHARMS USA INC | 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 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 (19)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-07-14 | LISTING_CONTEXT | Compound genus and independent claim 12 explicitly name canagliflozin or acceptable salt; no crystal/formulation restriction. | Source |
| PATENT | 2027-12-03 | LISTING_CONTEXT | Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | Source |
| PATENT | 2027-12-03 | LISTING_CONTEXT | Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | Source |
| PATENT | 2027-12-03 | LISTING_CONTEXT | Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | Source |
| PATENT | 2028-01-14 | CANONICAL_ANCHOR | Compound genus and independent claim 12 explicitly name canagliflozin or acceptable salt; no crystal/formulation restriction. | Source |
| PATENT | 2028-06-03 | FTO_TAIL | Canagliflozin hemihydrate crystal and treatment methods depending on that crystalline form. | Source |
| PATENT | 2029-02-26 | FTO_TAIL | Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | Source |
| PATENT | 2029-02-26 | FTO_TAIL | Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | Source |
| PATENT | 2029-02-26 | FTO_TAIL | Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | Source |
| PATENT | 2029-08-26 | FTO_TAIL | Canagliflozin hemihydrate crystal; method claims depend on the restricted crystalline form. | Source |
| PATENT | 2030-07-06 | FTO_TAIL | Canagliflozin/metformin formulation with fixed excipient percentage ranges. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Glycemic control in pediatric patients aged 10 years and older with T2D; adult glycemic and adult cardiovascular/diabetic-nephropathy benefits remain outside this population protection. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month extension of NPP: Glycemic control in pediatric patients aged 10 years and older with T2D; adult glycemic and adult cardiovascular/diabetic-nephropathy benefits remain outside this population protection. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH CANAGLIFLOZIN AND METFORMIN IS APPROPRIATE | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | NEW COMBINATION | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD) | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR | Source |
| REGULATORY_EXCLUSIVITY | 2018-03-29 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2028-01-14 | DECISION_BASIS | Rights after the canonical full-scope anchor require 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.