GenericRadar
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Product profile · United States

VOXZOGO

 ·  Patent Litigation & Settlement History ↓

IngredientVOSORITIDE
Application typeNDA
Application214938
Product003
Dosage formPOWDER
RouteSUBCUTANEOUS
Strength1.2MG/VIAL
Approval date2021-11-19
Marketing statusPrescription
Status event—
ApplicantBIOMARIN PHARM
Product source

Current GenericRadar decision

Year2035
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2035-06-11
Patent anchor2035-06-11
Exclusivity anchor2030-10-20
Protection date2042-07-11
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:214938:003; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
RE482672030-05-20U U-3927NYU
| B1C03P8 issued-claim review2026-10-15: U
———
RE482672030-05-20ORANGE_BOOK U-3927NYU
English description not available.
———
81982422035-06-11DS/DP/U U-3927YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
81982422035-06-11ORANGE_BOOK U-3927YNTRUE_DS
English description not available.
———
106465502036-08-01DP/U U-3927NNU
| B1C03P8 issued-claim review2026-10-15: U
———
106465502036-08-01ORANGE_BOOK U-3927NNU
English description not available.
———
115902042036-08-01DP/U U-3927NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
115902042036-08-01ORANGE_BOOK U-3927NNDP
English description not available.
———
119114462036-08-01U U-3927NNU
| B1C03P8 issued-claim review2026-10-15: U
———
119114462036-08-01ORANGE_BOOK U-3927NNU
English description not available.
———
125149062036-08-01DP/U U-3927NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
125149062036-08-01ORANGE_BOOK U-3927NNDP
English description not available.
———
99078342036-08-01DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
99078342036-08-01ORANGE_BOOK —NNDP
English description not available.
———
122331062042-07-11U U-3927NNU
| B1C03P8 issued-claim review2026-10-15: U
———
122331062042-07-11ORANGE_BOOK U-3927NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NPP2023-10-202026-10-20English description not available.NN——Source
NPP2023-10-202026-10-20English description not available.NN—
ODE-387 + ODE-449
Full coverage date: —
Source
NCE2021-11-192026-11-19English description not available.YY2026-11-19—Source
NCE2021-11-192026-11-19English description not available.YY2026-11-19
ODE-387 + ODE-449
Full coverage date: 2026-11-19
Source
ODE-3872021-11-192028-11-19English description not available.NN——Source
ODE-3872021-11-192028-11-19English description not available.NN—
ODE-387 + ODE-449
Full coverage date: —
Source
ODE-4492023-10-202030-10-20English description not available.NN——Source
ODE-4492023-10-202030-10-20English description not available.NN—
ODE-387 + ODE-449
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 (13)
TypeDateRoleBasisSource
PATENT2030-05-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-06-11CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-08-01FTO_TAILEnglish description not available.Source
PATENT2036-08-01FTO_TAILEnglish description not available.Source
PATENT2036-08-01FTO_TAILEnglish description not available.Source
PATENT2036-08-01FTO_TAILEnglish description not available.Source
PATENT2036-08-01FTO_TAILEnglish description not available.Source
PATENT2042-07-11FTO_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_STATUS2035-06-11CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:214938:003; 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.