Product profile · United States
SUSTOL
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2019 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6790458 | 2021-05-11 | DP — | N | N | DP Active agent in a semi-solid delivery vehicle requiring defined polyorthoester and selected compatible liquid excipient; broad active-agent wording does not remove formulation restrictions. | — | — | — |
| US6613355 | 2021-06-28 | DP — | N | N | DP Semi-solid delivery vehicle requires structurally specified polyorthoester with alpha-hydroxyacid units and selected compatible liquid excipient; not granisetron substance protection. | — | — | — |
| US10357570 | 2024-09-28 | U U-2253 | N | N | U_DP Nausea/vomiting method requires defined semi-solid polyorthoester, PEG monomethyl ether10-50 wt% and granisetron1-5 wt%, with molecular-weight and subunit restrictions. | — | — | — |
| US8252304 | 2024-09-28 | DP — | N | N | DP Independent compositions require defined polyorthoester, polyethylene-glycol monomethyl ether and granisetron1-5 wt%; other independent claims specify DETOSU/TEG/TEG-diGL reaction-product formulation. The 2012-11-20 certificate correcting claim formula drawings is preserved in the issued PDF. | — | — | — |
| US8252305 | 2024-09-28 | U U-1891 | N | N | U_DP Emesis-treatment method administers granisetron in a specifically defined semi-solid polyorthoester/PEG-monomethyl-ether composition. Formulation restrictions remain even with chemotherapy-use dependent claims. | — | — | — |
| US8715710 | 2024-09-28 | DP — | N | N | DP Semi-solid composition requires polyorthoester, PEG monomethyl ether10-50 wt%, granisetron1-5 wt%, and polymer molecular-weight/subunit restrictions. | — | — | — |
| US9913910 | 2024-09-28 | U U-2253 | N | N | U_DP Prophylactic nausea/vomiting method requires granisetron1-5 wt% in defined polyorthoester plus PEG monomethyl ether; acute/delayed chemotherapy dependent claims inherit the recipe. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NDF | 2016-08-09 | 2019-08-09 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NDF corresponds to the complete current exact injection scope: acute/delayed prevention with MEC or AC regimens in adults, in combination with other antiemetics. | Y | Y | 2019-08-09 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 (9)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2021-05-11 | FTO_TAIL | Active agent in a semi-solid delivery vehicle requiring defined polyorthoester and selected compatible liquid excipient; broad active-agent wording does not remove formulation restrictions. | Source |
| PATENT | 2021-06-28 | FTO_TAIL | Semi-solid delivery vehicle requires structurally specified polyorthoester with alpha-hydroxyacid units and selected compatible liquid excipient; not granisetron substance protection. | Source |
| PATENT | 2024-09-28 | FTO_TAIL | Independent compositions require defined polyorthoester, polyethylene-glycol monomethyl ether and granisetron1-5 wt%; other independent claims specify DETOSU/TEG/TEG-diGL reaction-product formulation. The 2012-11-20 certificate correcting claim formula drawings is preserved in the issued PDF. | Source |
| PATENT | 2024-09-28 | FTO_TAIL | Nausea/vomiting method requires defined semi-solid polyorthoester, PEG monomethyl ether10-50 wt% and granisetron1-5 wt%, with molecular-weight and subunit restrictions. | Source |
| PATENT | 2024-09-28 | FTO_TAIL | Prophylactic nausea/vomiting method requires granisetron1-5 wt% in defined polyorthoester plus PEG monomethyl ether; acute/delayed chemotherapy dependent claims inherit the recipe. | Source |
| PATENT | 2024-09-28 | FTO_TAIL | Semi-solid composition requires polyorthoester, PEG monomethyl ether10-50 wt%, granisetron1-5 wt%, and polymer molecular-weight/subunit restrictions. | Source |
| PATENT | 2024-09-28 | FTO_TAIL | Emesis-treatment method administers granisetron in a specifically defined semi-solid polyorthoester/PEG-monomethyl-ether composition. Formulation restrictions remain even with chemotherapy-use dependent claims. | Source |
| REGULATORY_EXCLUSIVITY | 2019-08-09 | CANONICAL_ANCHOR | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NDF corresponds to the complete current exact injection scope: acute/delayed prevention with MEC or AC regimens in adults, in combination with other antiemetics. | Source |
| REGULATORY_STATUS | 2019-08-09 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2019 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. | 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.