DHIVY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
APPROVAL_YEAR_FALLBACK: current product-specific evidence does not establish a DS/DS-equivalent or all-indication exclusivity anchor. US11033521/11439613/11819485 are limited by divided doses, tablet structure, continuous-IV simulation, and related conditions. Do not classify these use claims as essential across all approved uses. Retain the DP/U tail through 2039-03-28. Evidence limits: complete comparison of unverified ANDA candidates against original RLD documents remains incomplete; absence of generics is not established; complete historical patent/exclusivity collection remains incomplete.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11033521 | 2039-03-28 | DP/U U-219 | N | N | DP/U [GNR_US204_50] Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | — | — | — |
| 11033521 | 2039-03-28 | DP/U U-3304 | N | N | DP/U [GNR_US204_50] Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | — | — | — |
| 11033521 | 2039-03-28 | DP/U U-3305 | N | N | DP/U [GNR_US204_50] Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | — | — | — |
| 11033521 | 2039-03-28 | DP/U U-3305 | N | N | DP/U Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | — | — | — |
| 11033521 | 2039-03-28 | DP/U U-3304 | N | N | DP/U Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | — | — | — |
| 11033521 | 2039-03-28 | DP/U U-219 | N | N | DP/U Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | — | — | — |
| 11439613 | 2039-03-28 | U U-3557 | N | N | U [GNR_US204_50] Claim 1: CD 6.25-18.75/LD 25-75 mg, continuous-IV simulation, and exclusion of entacapone. | — | — | — |
| 11439613 | 2039-03-28 | U U-3557 | N | N | U Claim 1: CD 6.25-18.75/LD 25-75 mg, continuous-IV simulation, and exclusion of entacapone. | — | — | — |
| 11819485 | 2039-03-28 | U U-3557 | N | N | U [GNR_US204_50] Specific divided doses and administration method. Not established as essential across all approved uses. | — | — | — |
| 11819485 | 2039-03-28 | U U-3557 | N | N | U Specific divided doses and administration method. Not established as essential across all approved uses. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-10 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 073589 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1992-08-28 | — | DR REDDYS LABORATORIES SA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 074260 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 1993-09-03 | — | ACTAVIS ELIZABETH LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 073382 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1993-09-28 | — | WATSON LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 074080 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 1994-03-25 | — | SCS PHARMACEUTICALS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 073587 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1995-06-29 | — | ANI PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077120 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2008-06-02 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 078536 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2008-10-28 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090324 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2009-09-28 | — | PHARMOBEDIENT CONSULTING LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214092 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-05-07 | — | SCIEGEN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216505 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-09-21 | — | RUBICON RESEARCH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216537 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-11-28 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215999 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2023-04-04 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 218939 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-01-14 | — | ASCENT PHARMACEUTICALS 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 13 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 |
|---|---|---|---|---|---|---|
| 073589 / 001 | DR REDDYS LABORATORIES SA | FINAL_APPROVAL · FINAL_APPROVED | 1992-08-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 074260 / 002 | ACTAVIS ELIZABETH LLC | FINAL_APPROVAL · FINAL_APPROVED | 1993-09-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 073382 / 001 | WATSON LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 1993-09-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 074080 / 002 | SCS PHARMACEUTICALS | FINAL_APPROVAL · FINAL_APPROVED | 1994-03-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 073587 / 001 | ANI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 1995-06-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077120 / 002 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2008-06-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 078536 / 002 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2008-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090324 / 002 | PHARMOBEDIENT CONSULTING LLC | FINAL_APPROVAL · FINAL_APPROVED | 2009-09-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214092 / 002 | SCIEGEN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-05-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216505 / 002 | RUBICON RESEARCH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-09-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216537 / 002 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-11-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215999 / 002 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-04-04 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 218939 / 002 | ASCENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-01-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2039-03-28 | FTO_TAIL | Specific divided doses and administration method. Not established as essential across all approved uses. | Source |
| PATENT | 2039-03-28 | FTO_TAIL | Claim 1: CD 6.25-18.75/LD 25-75 mg, continuous-IV simulation, and exclusion of entacapone. | Source |
| PATENT | 2039-03-28 | FTO_TAIL | Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | Source |
| PATENT | 2039-03-28 | FTO_TAIL | Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | Source |
| PATENT | 2039-03-28 | FTO_TAIL | Claim 1: divided tablet, dose, and continuous-IV-simulation administration limitations. | 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.