GenericRadar
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Product profile · United States

VELTASSA

 ·  Patent Litigation & Settlement History ↓

IngredientPATIROMER SORBITEX CALCIUM
Application typeNDA
Application205739
Product001
Dosage formPOWDER
RouteORAL
StrengthEQ 8.4GM BASE/PACKET
Approval date2015-10-21
Marketing statusPrescription
Status event—
ApplicantVIFOR PHARMA
Product source

Current GenericRadar decision

Year2028
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2028-06-20
Patent anchor2028-06-20
Exclusivity anchor2020-10-21
Protection date2033-10-08
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:205739:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
82165602027-03-14U U-1766NNU
| B1C03P7 issued-claim review2026-10-15: U
———
82165602027-03-14ORANGE_BOOK U-1766NNU
English description not available.
———
82829132027-05-29DP —NYU
| B1C03P7 issued-claim review2026-10-15: U
———
82829132027-05-29ORANGE_BOOK —NYU
English description not available.
———
81478732028-06-20DP —NYU
| B1C03P7 issued-claim review2026-10-15: U
———
81478732028-06-20ORANGE_BOOK —NYU
English description not available.
———
83378242030-05-29DS/U U-1766NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
83378242030-05-29ORANGE_BOOK U-1766NNDP
English description not available.
———
111233632033-10-08U U-1766NNU
| B1C03P7 issued-claim review2026-10-15: U
———
111233632033-10-08ORANGE_BOOK U-1766NNU
English description not available.
———
94924762033-10-08U U-1766NNU
| B1C03P7 issued-claim review2026-10-15: U
———
94924762033-10-08ORANGE_BOOK U-1766NNU
English description not available.
———
99252122033-10-08U U-1766NNU
| B1C03P7 issued-claim review2026-10-15: U
———
99252122033-10-08ORANGE_BOOK U-1766NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2015-10-212020-10-21English description not available.YY2020-10-21
NCE
Full coverage date: 2020-10-21
Source
NPP2023-10-022026-10-02English description not available.NN——Source
NPP2023-10-022026-10-02English description not available.NN—
NCE
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 (10)
TypeDateRoleBasisSource
PATENT2027-03-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-05-29HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-06-20CANONICAL_ANCHOREnglish description not available.Source
PATENT2030-05-29FTO_TAILEnglish description not available.Source
PATENT2033-10-08FTO_TAILEnglish description not available.Source
PATENT2033-10-08FTO_TAILEnglish description not available.Source
PATENT2033-10-08FTO_TAILEnglish 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:205739:001; 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.