GenericRadar
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Product profile · United States

NEXLETOL

 ·  Patent Litigation & Settlement History ↓

IngredientBEMPEDOIC ACID
Application typeNDA
Application211616
Product001
Dosage formTABLET
RouteORAL
Strength180MG
Approval date2020-02-21
Marketing statusPrescription
Status event—
ApplicantESPERION THERAPS INC
Product source

Current GenericRadar decision

Year2030
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2030-12-03
Patent anchor2030-12-03
Exclusivity anchor2025-02-21
Protection date2040-06-19
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:211616:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
73357992030-12-03DS —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
73357992030-12-03ORANGE_BOOK —YNTRUE_DS
English description not available.
———
117448162036-03-14U U-3883NNU
| B1C03P7 issued-claim review2026-10-15: U
———
117448162036-03-14ORANGE_BOOK U-3883NNU
English description not available.
———
116135112040-06-19DS —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
116135112040-06-19ORANGE_BOOK —NNDP
English description not available.
———
117607142040-06-19DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
117607142040-06-19ORANGE_BOOK —NNDP
English description not available.
———
119265842040-06-19U U-3873NNU
| B1C03P7 issued-claim review2026-10-15: U
———
119265842040-06-19ORANGE_BOOK U-3873NNU
English description not available.
———
123980872040-06-19DS/DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
123980872040-06-19ORANGE_BOOK —NNDP
English description not available.
———
124042272040-06-19DS/U U-4258NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
124042272040-06-19ORANGE_BOOK U-4258NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2020-02-212025-02-21English description not available.YY2025-02-21
NCE
Full coverage date: 2025-02-21
Source
I-9432024-03-222027-03-22English description not available.NN——Source
I-9432024-03-222027-03-22English description not available.NN—
NCE
Full coverage date: —
Source
I-9442024-03-222027-03-22English description not available.NN——Source
I-9442024-03-222027-03-22English 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 (11)
TypeDateRoleBasisSource
PATENT2030-12-03CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-03-14FTO_TAILEnglish description not available.Source
PATENT2040-06-19FTO_TAILEnglish description not available.Source
PATENT2040-06-19FTO_TAILEnglish description not available.Source
PATENT2040-06-19FTO_TAILEnglish description not available.Source
PATENT2040-06-19FTO_TAILEnglish description not available.Source
PATENT2040-06-19FTO_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_STATUS2030-12-03CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:211616:001; 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.

Event datePartyEvent Licensed entryEvidenceSource
Not disclosed Multiple generic applicants SETTLEMENT 2040-04-19 REVIEW —
Reported no earlier than date; company breakdown pending