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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientAPOMORPHINE HYDROCHLORIDE
Application typeNDA
Application210875
Product003
Dosage formFILM
RouteSUBLINGUAL
Strength20MG
Approval date2020-05-21
Marketing statusDiscontinued
Status event—
ApplicantSUMITOMO PHARMA AM
Product source

Current GenericRadar decision

Year2025
SelectionWITHDRAWN
ReviewFINAL
Anchor typeWITHDRAWN
Anchor date2025-02-14
Patent anchor2030-06-11
Exclusivity anchor2023-05-21
Protection date—
First Final ANDA—
Status event2025-02-14

GNR judgment: WITHDRAWN. Reference year: 2025. Anchor type: WITHDRAWN. Patent anchor: 2030-06-11. Exclusivity anchor: 2023-05-21. Anchor date: 2025-02-14. 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
108210742029-08-07DP ————
———
104207632030-06-11DP/U U-2825———
———
90444752030-06-11DP ————
———
92832192030-06-11DP/U U-2825———
———
93269812030-06-11U U-2825———
———
96690192030-06-11DP/U U-2825———
———
96690212030-06-11U U-2825———
———
114197692031-12-16DP/U U-2825———
———
84149222031-12-16DP/U U-2825———
———
88460742031-12-16DP/U U-2825———
———
104491462036-04-19U U-2825———
———
109599432036-04-19U U-2825———
———

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.