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Product profile · United States

ESBRIET

 ·  Patent Litigation & Settlement History ↓

IngredientPIRFENIDONE
Application typeNDA
Application208780
Product002
Dosage formTABLET
RouteORAL
Strength534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval date2017-01-11
Marketing statusDiscontinued
Status event—
ApplicantLEGACY
Product source

Current GenericRadar decision

Year2017
SelectionDISCONTINUED
ReviewFINAL
Anchor typeDISCONTINUED
Anchor date—
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA2022-07-19
Status event—

GNR judgment: DISCONTINUED. Reference year: 2017. Anchor type: DISCONTINUED. Patent anchor: not recorded. Exclusivity anchor: not recorded. Anchor date: not recorded. Patent tail: not established. Exclusivity tail: not established. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
77677002027-12-18U U-2080———
———
84206742027-12-18U U-2079———
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83831502028-05-10DP/U U-2361———
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75667292029-04-22U U-2269———
———
75667292029-04-22U U-2270———
———
76357072029-04-22U U-2073———
———
76357072029-04-22U U-2075———
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76357072029-04-22U U-2074———
———
76357072029-04-22U U-2072———
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76357072029-04-22U U-2083———
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76357072029-04-22U U-2076———
———
85924622029-04-22U U-2056———
———
85924622029-04-22U U-2062———
———
85924622029-04-22U U-2055———
———
85924622029-04-22U U-2059———
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85924622029-04-22U U-2061———
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85924622029-04-22U U-2060———
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85924622029-04-22U U-2063———
———
85924622029-04-22U U-2058———
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85924622029-04-22U U-2057———
———
86097012029-04-22U U-2068———
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86097012029-04-22U U-2070———
———
86097012029-04-22U U-2064———
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86097012029-04-22U U-2066———
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86097012029-04-22U U-2067———
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86097012029-04-22U U-2069———
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86097012029-04-22U U-2065———
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78163832030-01-08U U-2050———
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78163832030-01-08U U-2042———
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79106102030-01-08U U-2049———
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79106102030-01-08U U-2048———
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80130022030-01-08U U-2082———
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80130022030-01-08U U-2047———
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80844752030-01-08U U-2054———
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80844752030-01-08U U-2268———
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83187802030-01-08U U-2081———
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83187802030-01-08U U-2046———
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86480982030-01-08U U-2052———
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86480982030-01-08U U-2051———
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87541092030-01-08U U-2053———
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87789472033-08-30U U-2045———
———
87789472033-08-30U U-2044———
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101886372037-03-28DP ————
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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.
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.