DAPTOMYCIN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US9655946 claim 18 and US10357535 claim 12 cover bacterial-infection treatment, compared against the NDA210282 citric-acid label. Internal DS-equivalent interpretation. No later tail identified. Citric-acid concentrations for 350 mg/7 mL and 500 mg/10 mL are approximately 40 mM, within the claim 1 range of 10-500 mM. Broad bacterial-infection use claims are considered difficult to avoid solely by indication carve-out. Formulation changes require separate FTO assessment. 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 |
|---|---|---|---|---|---|---|---|---|
| 10357535 | 2033-09-11 | DP/U U-3176 | N | Y | DS_EQUIVALENT [GNR_US204_50] Claim 12: bacterial-infection treatment; claim 1: 200-600 mg plus citric acid and reconstitution in 5-15 mL. Internal full-label use-claim interpretation. | — | — | — |
| 10357535 | 2033-09-11 | DP/U U-3176 | N | Y | DS_EQUIVALENT Claim 12: bacterial-infection treatment; claim 1: 200-600 mg plus citric acid and reconstitution in 5-15 mL. Internal full-label use-claim interpretation. | — | — | — |
| 9655946 | 2033-09-11 | DP/U U-3175 | N | Y | DS_EQUIVALENT [GNR_US204_50] Claim 18: bacterial-infection treatment plus product citric-acid formulation. Internal full-label use-claim interpretation. | — | — | — |
| 9655946 | 2033-09-11 | DP/U U-3175 | N | Y | DS_EQUIVALENT Claim 18: bacterial-infection treatment plus product citric-acid formulation. Internal full-label use-claim interpretation. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 212667 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-07-12 | — | ACCORD HEALTHCARE INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213425 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-20 | — | BE PHARMACEUTICALS AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211403 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-31 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213786 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-06-29 | — | MEITHEAL PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216445 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-12-23 | — | ASPIRO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213396 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-01 | — | FRESENIUS KABI USA LLC | 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 6 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 |
|---|---|---|---|---|---|---|
| 212667 / 001 | ACCORD HEALTHCARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-07-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213425 / 001 | BE PHARMACEUTICALS AG | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211403 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213786 / 001 | MEITHEAL PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-06-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216445 / 001 | ASPIRO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-12-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213396 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2033-09-11 | LISTING_CONTEXT | Claim 18: bacterial-infection treatment plus product citric-acid formulation. Internal full-label use-claim interpretation. | Source |
| PATENT | 2033-09-11 | CANONICAL_ANCHOR | Claim 12: bacterial-infection treatment; claim 1: 200-600 mg plus citric acid and reconstitution in 5-15 mL. Internal full-label use-claim interpretation. | 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.