Product profile · United States
OXYCONTIN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
APPROVAL_YEAR_FALLBACK: no qualifying TrueDS/DS-equivalent patent or full-scope exclusivity anchor.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11304908 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 11304908 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Opioid extended-release matrix constrained by PEO molecular weight and convection-heating process. | — | — | — |
| 11304909 | 2027-08-24 | U U-1556 | N | N | FORMULATION_USE | — | — | — |
| 11304909 | 2027-08-24 | U U-1556 | N | N | FORMULATION_USE Pain treatment requires the specifically heated PEO extended-release matrix. | — | — | — |
| 11964056 | 2027-08-24 | DP — | N | N | FORMULATION | — | — | — |
| 11964056 | 2027-08-24 | DP — | N | N | FORMULATION Oxycodone extended-release PEO matrix with named excipients, coating, dissolution and curing-density restrictions. | — | — | — |
| 12246094 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 12246094 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Oxycodone extended-release PEO matrix with heating, density, PK and dissolution restrictions. | — | — | — |
| 12280152 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 12280152 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Oxycodone PEO matrix constrained by curing, coating, dose, density and PK values. | — | — | — |
| 8808741 | 2027-08-24 | U U-1556 | N | N | FORMULATION_PROCESS_USE | — | — | — |
| 8808741 | 2027-08-24 | U U-1556 | N | N | FORMULATION_PROCESS_USE Pain method requires convection-cured oxycodone/PEO tablet with specified weight percentages and heating process. | — | — | — |
| 8894988 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 8894988 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Cured oxycodone/PEO tablet with fixed polymer molecular weight, dose/percentage and curing conditions. | — | — | — |
| 9492389 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 9492389 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Opioid PEO matrix with compression/air-curing process, polymer molecular weight and composition limits. | — | — | — |
| 9492391 | 2027-08-24 | U U-1556 | N | N | FORMULATION_PROCESS_USE | — | — | — |
| 9492391 | 2027-08-24 | U U-1556 | N | N | FORMULATION_PROCESS_USE Pain treatment requires a specified compression-shaped, air-cured opioid/PEO matrix. | — | — | — |
| 9492392 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 9492392 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Oxycodone PEO matrix with dose-dependent polymer percentages and curing process limits. | — | — | — |
| 9492393 | 2027-08-24 | U U-1556 | N | N | FORMULATION_PROCESS_USE | — | — | — |
| 9492393 | 2027-08-24 | U U-1556 | N | N | FORMULATION_PROCESS_USE Pain treatment requires oxycodone/PEO matrix with dose-dependent polymer percentages and air-curing process. | — | — | — |
| 9763933 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 9763933 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Opioid/PEO solid oral ER form with air-curing, cooling, hardness, molecular-weight and percentage requirements. | — | — | — |
| 9770416 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 9770416 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS PEO matrix, air curing, expansion and hardness requirements restrict independent claims; not unrestricted oxycodone protection. | — | — | — |
| 9775808 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 9775808 | 2027-08-24 | DP — | N | N | FORMULATION_PROCESS Independent claims require cured PEO extended-release oxycodone dosage forms and specified polymer content. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-153 | 2013-04-16 | 2016-04-16 | ADDITION OF INFORMATION REGARDING THE INTRANASAL ABUSE POTENTIAL OF OXYCONTIN | N | N | — | M-153 + NPP
Full coverage date: —
| Source |
| NPP | 2015-08-13 | 2018-08-13 | Opioid-tolerant pediatric patients aged 11 years and older with pain requiring daily, around-the-clock, long-term opioid treatment; adult scope is not covered. | N | N | — | M-153 + NPP
Full coverage date: —
| Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: NOT_COMPLETE
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 022272 / 005 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Purdue Pharma L.P. | Y | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 022272 / 005 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Purdue Pharma L.P. | Y | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076446 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | IMPAX PHARMS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076610 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | TEVA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077822 / 003 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | MALLINCKRODT | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 2 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 022272 / 005 | Purdue Pharma L.P. | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 022272 / 005 | Purdue Pharma L.P. | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last 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 / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last 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 / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (17)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-08-24 | FTO_TAIL | Opioid PEO matrix with compression/air-curing process, polymer molecular weight and composition limits. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Pain method requires convection-cured oxycodone/PEO tablet with specified weight percentages and heating process. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Independent claims require cured PEO extended-release oxycodone dosage forms and specified polymer content. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Opioid/PEO solid oral ER form with air-curing, cooling, hardness, molecular-weight and percentage requirements. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Oxycodone PEO matrix constrained by curing, coating, dose, density and PK values. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | PEO matrix, air curing, expansion and hardness requirements restrict independent claims; not unrestricted oxycodone protection. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Opioid extended-release matrix constrained by PEO molecular weight and convection-heating process. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Pain treatment requires a specified compression-shaped, air-cured opioid/PEO matrix. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Pain treatment requires oxycodone/PEO matrix with dose-dependent polymer percentages and air-curing process. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Oxycodone extended-release PEO matrix with heating, density, PK and dissolution restrictions. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Oxycodone extended-release PEO matrix with named excipients, coating, dissolution and curing-density restrictions. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Cured oxycodone/PEO tablet with fixed polymer molecular weight, dose/percentage and curing conditions. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Pain treatment requires the specifically heated PEO extended-release matrix. | Source |
| PATENT | 2027-08-24 | FTO_TAIL | Oxycodone PEO matrix with dose-dependent polymer percentages and curing process limits. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Opioid-tolerant pediatric patients aged 11 years and older with pain requiring daily, around-the-clock, long-term opioid treatment; adult scope is not covered. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ADDITION OF INFORMATION REGARDING THE INTRANASAL ABUSE POTENTIAL OF OXYCONTIN | Source |
| REGULATORY_STATUS | 2010-04-05 | DECISION_BASIS | APPROVAL_YEAR_FALLBACK: no qualifying TrueDS/DS-equivalent patent or full-scope exclusivity anchor. | 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.