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Product profile · United States

OXAYDO

 ·  Patent Litigation & Settlement History ↓

IngredientOXYCODONE HYDROCHLORIDE
Application typeNDA
Application202080
Product002
Dosage formTABLET
RouteORAL
Strength7.5MG
Approval date2011-06-17
Marketing statusDiscontinued
Status event—
ApplicantZYLA
Product source

Current GenericRadar decision

Year2023
SelectionDISCONTINUED
ReviewFINAL
Anchor typeCOMMERCIAL_STATUS
Anchor date—
Patent anchor—
Exclusivity anchor—
Protection date2025-03-16
First Final ANDA—
Status event—

MANUFACTURER_SCHEDULE_AND_YEAR_END_STATUS; canonical rights assessment 2011 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. Independently documented status year; exact day remains unknown.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
US75107262023-11-26DP —NNDP
Opioid/PEO/disintegrant/surfactant abuse-deterrent formulation.
———
US79814392023-11-26DP —NNDP
Drug/PEO/disintegrant/sodium-lauryl-sulfate composition; not an oxycodone compound claim.
———
US84096162023-11-26DP —NNDP
Water-soluble drug, gel-forming polymer, disintegrant and sorbitan-monoester formulation with weight-percent limits.
———
US86375402023-11-26DP —NNDP
Immediate-release opioid composition with gel-forming polymer, disintegrant and surfactant.
———
US94924432024-05-26DS/DP —NNDP
Immediate-release opioid/PEO/disintegrant/surfactant formulation; neither a new active compound nor broad pain-treatment claim.
———
US72019202025-03-16DP —NNDP
Opioid analgesic, gel-forming polyethylene oxide, disintegrant and nasal irritant, with an extraction limitation.
———

Regulatory exclusivity

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

2026-10-12 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · Historical coverage: ANNUALS_2011_2026_REVIEWED

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.
Decision evidence (7)
TypeDateRoleBasisSource
PATENT2023-11-26FTO_TAILWater-soluble drug, gel-forming polymer, disintegrant and sorbitan-monoester formulation with weight-percent limits.Source
PATENT2023-11-26FTO_TAILOpioid/PEO/disintegrant/surfactant abuse-deterrent formulation.Source
PATENT2023-11-26FTO_TAILImmediate-release opioid composition with gel-forming polymer, disintegrant and surfactant.Source
PATENT2023-11-26FTO_TAILDrug/PEO/disintegrant/sodium-lauryl-sulfate composition; not an oxycodone compound claim.Source
PATENT2024-05-26FTO_TAILImmediate-release opioid/PEO/disintegrant/surfactant formulation; neither a new active compound nor broad pain-treatment claim.Source
PATENT2025-03-16FTO_TAILOpioid analgesic, gel-forming polyethylene oxide, disintegrant and nasal irritant, with an extraction limitation.Source
REGULATORY_STATUS—TERMINAL_STATUSMANUFACTURER_SCHEDULE_AND_YEAR_END_STATUS; canonical rights assessment 2011 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. Independently documented status year; exact day remains unknown.Source
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.