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Product profile · United States

ADHANSIA XR

 ·  Patent Litigation & Settlement History ↓

IngredientMETHYLPHENIDATE HYDROCHLORIDE
Application typeNDA
Application212038
Product006
Dosage formCAPSULE, EXTENDED RELEASE
RouteORAL
Strength85MG
Approval date2019-02-27
Marketing statusDiscontinued
Status event—
ApplicantKNOA PHARMA
Product source

Current GenericRadar decision

Year2023
SelectionWITHDRAWN
ReviewFINAL
Anchor typeWITHDRAWN
Anchor date2023-01-09
Patent anchor—
Exclusivity anchor2022-02-27
Protection date—
First Final ANDA—
Status event2023-01-09

GNR judgment: WITHDRAWN. Reference year: 2023. Anchor type: WITHDRAWN. Patent anchor: not recorded. Exclusivity anchor: 2022-02-27. Anchor date: 2023-01-09. 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
101118392035-10-30U U-2357———
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102929382035-10-30DP ————
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102929392035-10-30DP/U U-2357———
———
104491592035-10-30U U-2357———
———
105001622035-10-30U U-2357———
———
105071862035-10-30DP ————
———
105126122035-10-30DP ————
———
105126132035-10-30U U-2357———
———
105688412035-10-30DP/U U-2357———
———
106880602035-10-30DP ————
———
99747522035-10-30DP ————
———
107224732038-11-19U U-2357———
———

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.