JARDIANCE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Final ANDA candidate 212138/002 on 2022-08-03. Source-level RLD/TE screen; earliest Final and exact Product source reference require independent review.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7713938 | 2027-04-15 | DS/DP — | — | — | — | — | — | — |
| 7713938 | 2027-10-15 | — — | — | — | — | — | 2027-10-15 | — |
| 7579449 | 2028-08-01 | DS — | — | — | — | — | — | — |
| 7579449 | 2029-02-01 | — — | — | — | — | — | 2029-02-01 | — |
| 8551957 | 2029-10-14 | U U-1651 | — | — | — | — | — | — |
| 12115179 | 2030-02-11 | U U-4023 | — | — | — | — | — | — |
| 8551957 | 2030-04-14 | — — | — | — | — | — | 2030-04-14 | — |
| 12115179 | 2030-08-11 | — — | — | — | — | — | 2030-08-11 | — |
| 12527810 | 2033-04-22 | U U-4403 | — | — | — | — | — | — |
| 12527810 | 2033-10-22 | — — | — | — | — | — | 2033-10-22 | — |
| 10258637 | 2034-04-03 | U U-2290 | — | — | — | — | — | — |
| 11090323 | 2034-04-03 | U U-3191 | — | — | — | — | — | — |
| 11833166 | 2034-04-03 | U U-3777 | — | — | — | — | — | — |
| 11833166 | 2034-04-03 | U U-3776 | — | — | — | — | — | — |
| 12263153 | 2034-04-03 | U U-4171 | — | — | — | — | — | — |
| 12427162 | 2034-04-03 | U U-4287 | — | — | — | — | — | — |
| 12433906 | 2034-04-03 | U U-4293 | — | — | — | — | — | — |
| 12433906 | 2034-04-03 | U U-4294 | — | — | — | — | — | — |
| 12433906 | 2034-04-03 | U U-4304 | — | — | — | — | — | — |
| 12433906 | 2034-04-03 | U U-4296 | — | — | — | — | — | — |
| 12433906 | 2034-04-03 | U U-4295 | — | — | — | — | — | — |
| 9949997 | 2034-05-17 | U U-2292 | — | — | — | — | — | — |
| 9949998 | 2034-06-11 | U U-2290 | — | — | — | — | — | — |
| 10258637 | 2034-10-03 | — — | — | — | — | — | 2034-10-03 | — |
| 11090323 | 2034-10-03 | — — | — | — | — | — | 2034-10-03 | — |
| 11833166 | 2034-10-03 | — — | — | — | — | — | 2034-10-03 | — |
| 12433906 | 2034-10-03 | — — | — | — | — | — | 2034-10-03 | — |
| 9949997 | 2034-11-17 | — — | — | — | — | — | 2034-11-17 | — |
| 9949998 | 2034-12-11 | — — | — | — | — | — | 2034-12-11 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | — | 2026-06-20 | — | — | — | — | Source | |
| PED | — | 2026-12-20 | — | — | — | — | Source |
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 |
|---|---|---|---|---|---|---|---|
| 212322 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | AIZANT | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212330 / 002 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | INVAGEN PHARMS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212343 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SUN PHARM INDS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212365 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ANNORA PHARMA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212382 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ALKEM LABS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212421 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | LAURUS GENERICS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212138 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-03 | — | ZYDUS PHARMACEUTICALS 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 1 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 |
|---|---|---|---|---|---|---|
| 212138 / 002 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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.