DAPTOMYCIN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US12053502 claims 1/2 cover Gram-positive infections, compared against the NDA217415 histidine/arginine label. Internal DS-equivalent interpretation. US12629337 DP tail expires 2043-01-09, after the anchor. Human-treatment claims have no age restriction and include pediatric scope. Label molecular weights/excipients imply a DAP:His:Arg molar ratio of approximately 1:3:5. Measured stability and design-around feasibility remain evidence limitations. 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; all-indication use claims are interpreted as DS-equivalent in the decision; formulation design-around feasibility and claim stability requirements require further assessment.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11759497 | 2038-08-28 | DP — | N | N | DP [GNR_US204_50] Claim 1: histidine plus amino-acid composition and stability limitations. | — | — | — |
| 11759497 | 2038-08-28 | DP — | N | N | DP Claim 1: histidine plus amino-acid composition and stability limitations. | — | — | — |
| 12053502 | 2038-08-28 | U U-3981 | N | Y | DS_EQUIVALENT [GNR_US204_50] Claim 1: Gram-positive infection treatment; claim 2: cSSSI and S. aureus bloodstream infections; no human age restriction. Product measurements for stability conditions are unavailable. | — | — | — |
| 12053502 | 2038-08-28 | U U-3981 | N | Y | DS_EQUIVALENT Claim 1: Gram-positive infection treatment; claim 2: cSSSI and S. aureus bloodstream infections; no human age restriction. Product measurements for stability conditions are unavailable. | — | — | — |
| 12629337 | 2043-01-09 | DP — | N | N | DP [GNR_US204_50] Claim 1: branched-chain amino-acid formulation and reconstitution-time limitations. | — | — | — |
| 12629337 | 2043-01-09 | DP — | N | N | DP Claim 1: branched-chain amino-acid formulation and reconstitution-time limitations. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 202857 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-09-12 | — | HOSPIRA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091039 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-03-25 | — | TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206005 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-15 | — | XELLIA PHARMACEUTICALS APS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206077 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-04-11 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205037 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-06-05 | — | MYLAN LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208375 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-01 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211961 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-06-24 | — | ACCORD HEALTHCARE INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212513 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-06-26 | — | BE PHARMACEUTICALS AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212022 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-08-22 | — | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207104 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-15 | — | SAGENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212250 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-21 | — | HISUN PHARMACEUTICAL HANGZHOU CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213623 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-06-29 | — | MEITHEAL PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215316 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-08-24 | — | QILU PHARMACEUTICAL HAINAN CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213171 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-09-02 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215215 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-26 | — | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215890 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-18 | — | HAINAN POLY PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216413 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-09-23 | — | ASPIRO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213966 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-08-07 | — | MYLAN PHARMACEUTICALS INC A VIATRIS CO | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217215 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-29 | — | BIOCON PHARMA LTD | 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 19 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 |
|---|---|---|---|---|---|---|
| 202857 / 001 | HOSPIRA INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-09-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091039 / 001 | TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-03-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206005 / 001 | XELLIA PHARMACEUTICALS APS | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206077 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2018-04-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205037 / 001 | MYLAN LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-06-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208375 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211961 / 001 | ACCORD HEALTHCARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-06-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212513 / 001 | BE PHARMACEUTICALS AG | FINAL_APPROVAL · FINAL_APPROVED | 2019-06-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212022 / 001 | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-08-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207104 / 001 | SAGENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212250 / 001 | HISUN PHARMACEUTICAL HANGZHOU CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213623 / 001 | MEITHEAL PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-06-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215316 / 001 | QILU PHARMACEUTICAL HAINAN CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-08-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213171 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-09-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215215 / 001 | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215890 / 001 | HAINAN POLY PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216413 / 001 | ASPIRO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-09-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213966 / 001 | MYLAN PHARMACEUTICALS INC A VIATRIS CO | FINAL_APPROVAL · FINAL_APPROVED | 2023-08-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217215 / 001 | BIOCON PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2038-08-28 | CANONICAL_ANCHOR | Claim 1: Gram-positive infection treatment; claim 2: cSSSI and S. aureus bloodstream infections; no human age restriction. Product measurements for stability conditions are unavailable. | Source |
| PATENT | 2038-08-28 | LISTING_CONTEXT | Claim 1: histidine plus amino-acid composition and stability limitations. | Source |
| PATENT | 2043-01-09 | FTO_TAIL | Claim 1: branched-chain amino-acid formulation and reconstitution-time 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.