Product profile · United States
SELZENTRY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_DISC_PROCESSING_YEAR_USER_ACCEPTED_BASIS; canonical 2023 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA DISC processing month/year adopted under the user instruction. Actual commercial cessation day is not invented.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6586430 | 2019-12-01 | DS/DP/U U-824 | Y | N | TRUE_DS Independent compound claim1 protects the four-region chemical genus and salts without mandatory excipient/device/crystal limitation. Region-alpha amide/fluoro-substituted cyclohexyl, alkyl bridge and tropane region-gamma correspond to maraviroc; region-delta branch C explicitly includes triazolyl rings and alkyl substituents. Review includes this branch rather than stopping at branch A's two-nitrogen-ring examples. | — | — | — |
| US7576097 | 2021-11-25 | DS/PED — | N | N | DP_SOLID_STATE Independent claims1 and4 protect crystalline polymorph Forms A and B of maraviroc; dependent claims define XRPD peaks. Not maraviroc irrespective of solid state. | — | 2021-11-25 | — |
| US6667314 | 2022-02-06 | DS/DP/U/PED U-824 | Y | N | TRUE_DS Independent compound claim1 covers the tropane/triazole genus and salts/solvates; claim8 expressly names the1S,4,4-difluorocyclohexanecarboxamide species corresponding to maraviroc. No mandatory crystalline form or formulation restriction in the broad compound claim. | — | 2022-02-06 | — |
| US7368460 | 2023-05-25 | U/PED U-824 | N | Y | DS_EQUIVALENT Independent methods treat CCR5-modulated HIV infection using the maraviroc compound class; claim3 expressly names maraviroc. SELZENTRY sole approved therapeutic indication is combination treatment of CCR5-tropic HIV-1, including labeled pediatric use. Claims do not require formulation, crystal, strength, age, prior-treatment or dosing subgroups, so all approved uses of the exact25mg/75mg tablets and20mg/mL oral solution fall within the broad method. | — | 2023-05-25 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | 2016-11-04 | 2019-11-04 | PARTIAL_PEDIATRIC_POPULATION; NS is exact-strength protection through2019-11-04; NPP is separately pediatric. The2020 label differentiates tablets at age2/10kg from oral solution at2kg. No solution-only PED or NPP row is transferred to25mg/75mg tablets. | Y | N | — | Source | |
| NS | 2016-11-04 | 2019-11-04 | FULL_EXACT_STRENGTH_SCOPE; NS is exact-strength protection through2019-11-04; NPP is separately pediatric. The2020 label differentiates tablets at age2/10kg from oral solution at2kg. No solution-only PED or NPP row is transferred to25mg/75mg tablets. | Y | Y | 2019-11-04 | 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 (7)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2019-12-01 | LISTING_CONTEXT | Independent compound claim1 protects the four-region chemical genus and salts without mandatory excipient/device/crystal limitation. Region-alpha amide/fluoro-substituted cyclohexyl, alkyl bridge and tropane region-gamma correspond to maraviroc; region-delta branch C explicitly includes triazolyl rings and alkyl substituents. Review includes this branch rather than stopping at branch A's two-nitrogen-ring examples. | Source |
| PATENT | 2021-11-25 | LISTING_CONTEXT | Independent claims1 and4 protect crystalline polymorph Forms A and B of maraviroc; dependent claims define XRPD peaks. Not maraviroc irrespective of solid state. | Source |
| PATENT | 2022-02-06 | LISTING_CONTEXT | Independent compound claim1 covers the tropane/triazole genus and salts/solvates; claim8 expressly names the1S,4,4-difluorocyclohexanecarboxamide species corresponding to maraviroc. No mandatory crystalline form or formulation restriction in the broad compound claim. | Source |
| PATENT | 2023-05-25 | CANONICAL_ANCHOR | Independent methods treat CCR5-modulated HIV infection using the maraviroc compound class; claim3 expressly names maraviroc. SELZENTRY sole approved therapeutic indication is combination treatment of CCR5-tropic HIV-1, including labeled pediatric use. Claims do not require formulation, crystal, strength, age, prior-treatment or dosing subgroups, so all approved uses of the exact25mg/75mg tablets and20mg/mL oral solution fall within the broad method. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | PARTIAL_PEDIATRIC_POPULATION; NS is exact-strength protection through2019-11-04; NPP is separately pediatric. The2020 label differentiates tablets at age2/10kg from oral solution at2kg. No solution-only PED or NPP row is transferred to25mg/75mg tablets. | Source |
| REGULATORY_EXCLUSIVITY | 2019-11-04 | SCOPE_CONTEXT | FULL_EXACT_STRENGTH_SCOPE; NS is exact-strength protection through2019-11-04; NPP is separately pediatric. The2020 label differentiates tablets at age2/10kg from oral solution at2kg. No solution-only PED or NPP row is transferred to25mg/75mg tablets. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA_DISC_PROCESSING_YEAR_USER_ACCEPTED_BASIS; canonical 2023 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA DISC processing month/year adopted under the user instruction. Actual commercial cessation day is not invented. | 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.