GenericRadar
Market LIVE
Published markets; coverage varies by country
Product profile · United States

PYRUKYND

 ·  Patent Litigation & Settlement History ↓

IngredientMITAPIVAT SULFATE
Application typeNDA
Application216196
Product002
Dosage formTABLET
RouteORAL
StrengthEQ 20MG BASE
Approval date2022-02-17
Marketing statusPrescription
Status event—
ApplicantAGIOS PHARMS INC
Product source

Current GenericRadar decision

Year2038
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2038-10-11
Patent anchor2038-10-11
Exclusivity anchor2029-02-17
Protection date2041-07-31
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:216196:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
106321142032-05-03U U-3320NYU
English description not available.
———
106321142032-05-03ORANGE_BOOK U-3320NYU
English description not available.
———
96820802032-05-03U U-3319NYU
English description not available.
———
96820802032-05-03ORANGE_BOOK U-3319NYU
English description not available.
———
99809612032-05-03U U-3319NYU
English description not available.
———
99809612032-05-03ORANGE_BOOK U-3319NYU
English description not available.
———
91937012032-10-26U U-3319NYU
English description not available.
———
91937012032-10-26ORANGE_BOOK U-3319NYU
English description not available.
———
117938062033-04-12U U-3320NYU
English description not available.
———
117938062033-04-12ORANGE_BOOK U-3320NYU
English description not available.
———
RE495822035-04-11DS/DP —YNTRUE_DS
English description not available.
———
RE495822035-04-11ORANGE_BOOK —YNTRUE_DS
English description not available.
———
112349762038-10-11U U-3321NYU
English description not available.
———
112349762038-10-11ORANGE_BOOK U-3321NYU
English description not available.
———
112546522038-11-21DS/DP —NNDP
English description not available.
———
112546522038-11-21ORANGE_BOOK —NNDP
English description not available.
———
118780492041-07-31U U-3782NNU
English description not available.
———
118780492041-07-31ORANGE_BOOK U-3782NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2022-02-172027-02-17English description not available.YY2027-02-17—Source
NCE2022-02-172027-02-17English description not available.YY2027-02-17
ODE-392
Full coverage date: 2027-02-17
Source
ODE-3922022-02-172029-02-17English description not available.YY2029-02-17—Source
ODE-3922022-02-172029-02-17English description not available.YY2029-02-17
ODE-392
Full coverage date: 2029-02-17
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
PATENT2032-05-03HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-05-03HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-05-03HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-10-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-04-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-04-11HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-11CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-11-21FTO_TAILEnglish description not available.Source
PATENT2041-07-31FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2038-10-11CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:216196:002; 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.