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Product profile · United States

PENNSAID

 ·  Patent Litigation & Settlement History ↓

IngredientDICLOFENAC SODIUM
Application typeNDA
Application204623
Product001
Dosage formSOLUTION
RouteTOPICAL
Strength2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval date2014-01-16
Marketing statusDiscontinued
Status event—
ApplicantHORIZON
Product source

Current GenericRadar decision

Year2024
SelectionDISCONTINUED
ReviewFINAL
Anchor typeDISCONTINUED
Anchor date—
Patent anchor2027-10-17
Exclusivity anchor2017-01-16
Protection date—
First Final ANDA—
Status event—

GNR judgment: DISCONTINUED. Reference year: 2024. Anchor type: DISCONTINUED. Patent anchor: 2027-10-17. Exclusivity anchor: 2017-01-16. 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
85636132027-10-17DP/U U-1488———
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88718092027-10-17U U-1614———
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90669132027-10-17DP/U U-1488———
———
91015912027-10-17DP/U U-1488———
———
91321102027-10-17U U-1488———
———
91683042027-10-17DP ————
———
91683052027-10-17U U-1488———
———
92207842027-10-17U U-1488———
———
93395512027-10-17U U-1488———
———
93395522027-10-17DP/U U-1488———
———
95393352027-10-17U U-1614———
———
82528382028-04-21DP/U U-1489———
———
82170782029-07-10U U-1477———
———
86181642029-07-10U U-1477———
———
87419562029-07-10U U-1435———
———
93705012029-07-10U U-1614———
———
93754122029-07-10U U-1614———
———
94150292029-07-10U U-1614———
———
85464502030-08-09U U-1435———
———
85464502030-08-09U U-1436———
———

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.