GenericRadar
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Product profile · United States

EVRYSDI

 ·  Patent Litigation & Settlement History ↓

IngredientRISDIPLAM
Application typeNDA
Application219285
Product001
Dosage formTABLET
RouteORAL
Strength5MG
Approval date2025-02-11
Marketing statusPrescription
Status event—
ApplicantGENENTECH INC
Product source

Current GenericRadar decision

Year2038
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2038-10-04
Patent anchor2038-10-04
Exclusivity anchor2027-08-07
Protection date2041-04-15
First Final ANDA—
Status event—

ANCHOR_WITH_TAIL; US:NDA:219285:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
95869552034-08-07DS/DP —YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
95869552034-08-07ORANGE_BOOK —YNTRUE_DS
English description not available.
———
99697542035-05-11DS/DP/U U-1943YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
99697542035-05-11ORANGE_BOOK U-1943YNTRUE_DS
English description not available.
———
118276462036-01-25U U-1943NYU
| B1C03 issued-claim review2026-10-15: U
———
118276462036-01-25ORANGE_BOOK U-1943NYU
English description not available.
———
123502732038-10-01U U-1943NYU
| B1C03 issued-claim review2026-10-15: U
———
123502732038-10-01ORANGE_BOOK U-1943NYU
English description not available.
———
115344442038-10-04U U-1943NYU
| B1C03 issued-claim review2026-10-15: U
———
115344442038-10-04ORANGE_BOOK U-1943NYU
English description not available.
———
121227892041-04-15DS/DP —NNDP
| B1C03 issued-claim review2026-10-15: DP
———
121227892041-04-15ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NPP2022-05-272025-05-27English description not available.NN—
ODE-334
Full coverage date: —
Source
NCE2020-08-072025-08-07English description not available.YY2025-08-07
ODE-334
Full coverage date: 2025-08-07
Source
M-2702023-10-032026-10-03English description not available.NN——Source
M-2702023-10-032026-10-03English description not available.NN—
ODE-334
Full coverage date: —
Source
ODE-3342020-08-072027-08-07English description not available.YY2027-08-07
ODE-334
Full coverage date: 2027-08-07
Source
ODE-4002022-05-272029-05-27English description not available.NN—
ODE-334
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
PATENT2034-08-07HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-05-11HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2036-01-25HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-01HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-04CANONICAL_ANCHOREnglish description not available.Source
PATENT2041-04-15FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2038-10-04CANONICAL_DECISIONANCHOR_WITH_TAIL; US:NDA:219285:001; 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.