GenericRadar
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Product profile · United States

QULIPTA

 ·  Patent Litigation & Settlement History ↓

IngredientATOGEPANT
Application typeNDA
Application215206
Product002
Dosage formTABLET
RouteORAL
Strength30MG
Approval date2021-09-28
Marketing statusPrescription
Status event—
ApplicantABBVIE
Product source

Current GenericRadar decision

Year2035
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2035-09-28
Patent anchor2035-09-28
Exclusivity anchor2026-09-28
Protection date2042-09-27
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:215206:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
94995452031-11-10DS/DP/U U-3534YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
94995452031-11-10ORANGE_BOOK U-3534YNTRUE_DS
English description not available.
———
98502462033-03-13DS —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
98502462033-03-13ORANGE_BOOK —NNDP
English description not available.
———
101178362035-01-30DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
101178362035-01-30ORANGE_BOOK —NNDP
English description not available.
———
87540962035-09-28DS/DP/U U-3534YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
87540962035-09-28ORANGE_BOOK U-3534YNTRUE_DS
English description not available.
———
123835452039-06-06U U-3534NNU
| B1C03P7 issued-claim review2026-10-15: U
———
123835452039-06-06ORANGE_BOOK U-3534NNU
English description not available.
———
120901482041-07-29U U-3534NNU
| B1C03P7 issued-claim review2026-10-15: U
———
120901482041-07-29ORANGE_BOOK U-3534NNU
English description not available.
———
126228972042-09-27U U-4536NNU
| B1C03P7 issued-claim review2026-10-15: U
———
126228972042-09-27ORANGE_BOOK U-4536NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
I-9092023-04-172026-04-17English description not available.NN——Source
I-9092023-04-172026-04-17English description not available.NN—
NCE
Full coverage date: —
Source
NCE2021-09-282026-09-28English description not available.YY2026-09-28—Source
NCE2021-09-282026-09-28English description not available.YY2026-09-28
NCE
Full coverage date: 2026-09-28
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
PATENT2031-11-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-03-13HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-01-30HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-09-28CANONICAL_ANCHOREnglish description not available.Source
PATENT2039-06-06FTO_TAILEnglish description not available.Source
PATENT2041-07-29FTO_TAILEnglish description not available.Source
PATENT2042-09-27FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2035-09-28CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:215206:002; 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.