GenericRadar
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Product profile · United States

SIVEXTRO

 ·  Patent Litigation & Settlement History ↓

IngredientTEDIZOLID PHOSPHATE
Application typeNDA
Application205435
Product001
Dosage formTABLET
RouteORAL
Strength200MG
Approval date2014-06-20
Marketing statusPrescription
Status event—
ApplicantCUBIST PHARMS LLC
Product source

Current GenericRadar decision

Year2028
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2028-06-20
Patent anchor2028-06-20
Exclusivity anchor2024-06-20
Protection date2030-12-31
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:205435:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
84206762028-02-23DS/DP/U U-282YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
84206762028-02-23ORANGE_BOOK U-282YNTRUE_DS
English description not available.
———
78163792028-06-20DS/DP/U U-2507YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
78163792028-06-20ORANGE_BOOK U-2507YNTRUE_DS
English description not available.
———
100659472030-02-03DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
100659472030-02-03ORANGE_BOOK —NNDP
English description not available.
———
104428292030-02-03DS —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
104428292030-02-03ORANGE_BOOK —NNDP
English description not available.
———
96242502030-02-03DS/DP/U U-2507NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
96242502030-02-03ORANGE_BOOK U-2507NNDP
English description not available.
———
99884062030-02-03DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
99884062030-02-03ORANGE_BOOK —NNDP
English description not available.
———
84263892030-12-31DS/DP/U U-282NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
84263892030-12-31ORANGE_BOOK U-282NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2014-06-202019-06-20English description not available.YY2019-06-20
GAIN
Full coverage date: 2019-06-20
Source
NPP2020-06-192023-06-19English description not available.NN—
GAIN
Full coverage date: —
Source
GAIN2014-06-202024-06-20English description not available.YY2024-06-20
GAIN
Full coverage date: 2024-06-20
Source
NPP2025-04-042028-04-04English description not available.NN——Source
NPP2025-04-042028-04-04English description not available.NN—
GAIN
Full coverage date: —
Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
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.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast 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 / productApplicantEvent / status First marketed Product mappingSourceLast 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 / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast 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 / productApplicantEvent / status Certification event date Product mappingSourceLast 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 / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Decision evidence (12)
TypeDateRoleBasisSource
PATENT2028-02-23HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-06-20CANONICAL_ANCHOREnglish description not available.Source
PATENT2030-02-03FTO_TAILEnglish description not available.Source
PATENT2030-02-03FTO_TAILEnglish description not available.Source
PATENT2030-02-03FTO_TAILEnglish description not available.Source
PATENT2030-02-03FTO_TAILEnglish description not available.Source
PATENT2030-12-31FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2028-06-20CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:205435:001; exact Final ANDA not verified; not proof of generic absenceSource
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.