OPANA ER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA approval of this entire NDA and its strengths was withdrawn effective 2020-12-23. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8808737 | 2027-06-21 | U U-1598 | N | N | PATIENT_SUBGROUP_DOSING | — | — | — |
| 8808737 | 2027-06-21 | U U-1598 | N | N | PATIENT_SUBGROUP_DOSING Independent claims restrict controlled-release oxymorphone pain treatment to renally impaired patients, creatinine-clearance assessment and exposure/dose limitations. | — | — | — |
| 7851482 | 2029-07-10 | DS — | N | N | ACTIVE_INGREDIENT_IMPURITY_LIMIT | — | — | — |
| 7851482 | 2029-07-10 | DS — | N | N | ACTIVE_INGREDIENT_IMPURITY_LIMIT Independent claims require low-ABUK oxymorphone hydrochloride. The court record documents the less-than-10-ppm FDA pathway, but also describes a higher-level non-genotoxicity justification pathway. No proof that every approvable alternative must meet the claimed limit is established. Retain TrueDS N and DS-equivalent N rather than automatically promoting a quality threshold. | — | — | — |
| 8871779 | 2029-11-22 | DS — | N | N | ACTIVE_INGREDIENT_IMPURITY_LIMIT | — | — | — |
| 8871779 | 2029-11-22 | DS — | N | N | ACTIVE_INGREDIENT_IMPURITY_LIMIT Independent claims require low-ABUK oxymorphone hydrochloride. The court record documents the less-than-10-ppm FDA pathway, but also describes a higher-level non-genotoxicity justification pathway. No proof that every approvable alternative must meet the claimed limit is established. Retain TrueDS N and DS-equivalent N rather than automatically promoting a quality threshold. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-11 · CURRENT_SNAPSHOT_NO_RECORD · 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 |
|---|---|---|---|---|---|---|---|
| 079087 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2010-07-22 | — | IMPAX LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079046 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2013-07-11 | — | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 200822 / 007 | FINAL_APPROVAL · FINAL_APPROVED | 2013-07-15 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202946 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-27 | — | SPECGX LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 200792 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2014-10-24 | — | PAR PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203506 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2015-04-24 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | 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 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last 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 / 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 6 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 |
|---|---|---|---|---|---|---|
| 079087 / 006 | IMPAX LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2010-07-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 079046 / 006 | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2013-07-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 200822 / 007 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2013-07-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202946 / 006 | SPECGX LLC | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 200792 / 006 | PAR PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-10-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203506 / 006 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-04-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-06-21 | FTO_TAIL | Independent claims restrict controlled-release oxymorphone pain treatment to renally impaired patients, creatinine-clearance assessment and exposure/dose limitations. | Source |
| PATENT | 2029-07-10 | FTO_TAIL | Independent claims require low-ABUK oxymorphone hydrochloride. The court record documents the less-than-10-ppm FDA pathway, but also describes a higher-level non-genotoxicity justification pathway. No proof that every approvable alternative must meet the claimed limit is established. Retain TrueDS N and DS-equivalent N rather than automatically promoting a quality threshold. | Source |
| PATENT | 2029-11-22 | FTO_TAIL | Independent claims require low-ABUK oxymorphone hydrochloride. The court record documents the less-than-10-ppm FDA pathway, but also describes a higher-level non-genotoxicity justification pathway. No proof that every approvable alternative must meet the claimed limit is established. Retain TrueDS N and DS-equivalent N rather than automatically promoting a quality threshold. | Source |
| REGULATORY_STATUS | 2020-12-23 | TERMINAL_STATUS | FDA approval of this entire NDA and its strengths was withdrawn effective 2020-12-23. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date. | Source |
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.