Product profile · United States
TARGINIQ
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2017 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6277384 | 2018-12-22 | DP — | N | N | DP_U Opioid agonist/antagonist oral dosage form with ratio-dependent analgesia, aversion in dependent subjects and non-increased efficacy properties. No new oxycodone/naloxone molecule or unrestricted full-label pain method. | — | — | — |
| US6696066 | 2018-12-22 | DP — | N | N | DP_U Sustained-release opioid agonist/antagonist dosage form with ratio, aversion, analgesia and once/twice-daily administration restrictions. | — | — | — |
| US8673355 | 2018-12-22 | DP — | N | N | DP_U Sustained-release opioid/antagonist matrix with ratio-dependent aversive/analgesic performance and once/twice-daily use. | — | — | — |
| US8822487 | 2018-12-22 | DP — | N | N | DP_U Sustained-release oral agonist/antagonist combination with dose, carrier and aversion limitations; not a new active compound. | — | — | — |
| US9205082 | 2018-12-22 | DP/U U-1556 | N | N | DP_U Sustained-release opioid agonist/antagonist form with equianalgesic dose range, carrier and aversive/analgesic conditions. | — | — | — |
| US9474750 | 2018-12-22 | DP/U U-1556 | N | N | DP_U Sustained-release agonist/antagonist dosage form with carrier, aversion and therapeutic-performance restrictions; broad title does not create an active-compound or unrestricted full-label method. | — | — | — |
| US8969369 | 2022-05-10 | DP/U U-1556 | N | N | DP_U Oxycodone/naloxone controlled-release matrix with dose/ratio limits and more-than90% naloxone release over10 hours; recipe/release conditions prevent unrestricted clinical-method promotion. | — | — | — |
| US9056051 | 2022-05-10 | DP/U U-1556 | N | N | DP_U Oxycodone/naloxone ratio5:1–1:1 and more-than90% naloxone release over10 hours; related methods inherit composition restrictions. | — | — | — |
| US9084729 | 2022-05-10 | DP/U U-1556 | N | N | DP_U Oxycodone/naloxone5:1–1:1 controlled-release composition with substantially all naloxone released over8–12 hours; conditional formulation rather than active-compound monopoly. | — | — | — |
| US9161937 | 2022-05-10 | DP/U U-1556 | N | N | DP_U Controlled-release oxycodone/naloxone5:1–1:1 composition with65.9–95.9% naloxone release over4 hours. | — | — | — |
| US9168252 | 2022-05-10 | DP/U U-1556 | N | N | DP_U Controlled-release oxycodone/naloxone composition with ratio and at-least87.5% naloxone release over8–12 hours. | — | — | — |
| US9283216 | 2022-05-10 | DP/U U-1819 | N | N | DP_U Controlled-release oxycodone/naloxone ratio and45.4–78% naloxone release over2 hours. | — | — | — |
| US9283221 | 2022-05-10 | DP/U U-1819 | N | N | DP_U Controlled-release oxycodone/naloxone ratio and57.4–90% naloxone release over3 hours. | — | — | — |
| US9345701 | 2022-05-10 | DP/U U-1819 | N | N | DP_U USPTO B1 claim1 requires oxycodone/naloxone ratio5:1–1:1 and approximately equal release rates; pain-treatment claim28 inherits that composition. The2017-03-28 certificate corrects claim30 from method to pharmaceutical composition. | — | — | — |
| US9511066 | 2022-05-10 | U U-1921 | N | N | U_DP Independent method prevents abuse by providing a specified controlled-release oxycodone/naloxone composition with ratio and timed-release constraints. Abuse prevention is not the sole labeled severe-pain indication. | — | — | — |
| US8846090 | 2023-04-04 | DP — | N | N | DP Oxycodone/naloxone diffusion matrix containing ethylcellulose and fatty alcohol with quantitative content and invariant independent release constraints. | — | — | — |
| US8846091 | 2023-04-04 | DP — | N | N | DP Oxycodone/naloxone2:1 matrix with specified agonist dose, ethylcellulose1–15% and fatty alcohol10–25%. | — | — | — |
| US7674799 | 2025-03-30 | DP — | N | N | DP_PROCESS Oxycodone oral dosage forms with coated particles, sustained-release material and less-than25 ppm impurity sourced from a specified chemical conversion. Purity/process/formulation restrictions remain. | — | — | — |
| US7674800 | 2025-03-30 | DS — | N | N | PROCESS Independent claim1 requires preparation/incubation and preferential removal of14-hydroxycodeinone; other claims address the specified salt-production/purification sequence. Not broad oxycodone chemical identity. | — | — | — |
| US7683072 | 2025-03-30 | DS — | N | N | DP_PROCESS Oxycodone API with less-than25 ppm14-hydroxycodeinone and a specified impurity provenance. Substance quality/product-by-process limitation, not unrestricted old-active compound protection. | — | — | — |
| US9073933 | 2025-03-30 | DS — | N | N | DP_PROCESS At-least95% oxycodone HCl composition with named dihydroxy impurity and less-than25 ppm14-hydroxycodeinone, plus impurity-removal process claims. | — | — | — |
| US9522919 | 2025-03-30 | DS/DP — | N | N | DP_PROCESS Oxycodone HCl with a named impurity/API ratio of0.04% or less measured byHPLC; purity and production/formulation restrictions remain. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NC | 2014-07-23 | 2017-07-23 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NC covers the exact oxycodone/naloxone extended-release combination at all three target strengths for severe pain requiring daily around-the-clock long-term opioid treatment when alternatives are inadequate. Abuse-deterrence study descriptions are not additional approved pain indications. | Y | Y | 2017-07-23 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| 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.
| 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 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 (24)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2018-12-22 | FTO_TAIL | Sustained-release opioid agonist/antagonist dosage form with ratio, aversion, analgesia and once/twice-daily administration restrictions. | Source |
| PATENT | 2018-12-22 | FTO_TAIL | Sustained-release oral agonist/antagonist combination with dose, carrier and aversion limitations; not a new active compound. | Source |
| PATENT | 2018-12-22 | FTO_TAIL | Sustained-release opioid/antagonist matrix with ratio-dependent aversive/analgesic performance and once/twice-daily use. | Source |
| PATENT | 2018-12-22 | FTO_TAIL | Sustained-release opioid agonist/antagonist form with equianalgesic dose range, carrier and aversive/analgesic conditions. | Source |
| PATENT | 2018-12-22 | FTO_TAIL | Opioid agonist/antagonist oral dosage form with ratio-dependent analgesia, aversion in dependent subjects and non-increased efficacy properties. No new oxycodone/naloxone molecule or unrestricted full-label pain method. | Source |
| PATENT | 2018-12-22 | FTO_TAIL | Sustained-release agonist/antagonist dosage form with carrier, aversion and therapeutic-performance restrictions; broad title does not create an active-compound or unrestricted full-label method. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Oxycodone/naloxone5:1–1:1 controlled-release composition with substantially all naloxone released over8–12 hours; conditional formulation rather than active-compound monopoly. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Independent method prevents abuse by providing a specified controlled-release oxycodone/naloxone composition with ratio and timed-release constraints. Abuse prevention is not the sole labeled severe-pain indication. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Oxycodone/naloxone controlled-release matrix with dose/ratio limits and more-than90% naloxone release over10 hours; recipe/release conditions prevent unrestricted clinical-method promotion. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Controlled-release oxycodone/naloxone composition with ratio and at-least87.5% naloxone release over8–12 hours. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | USPTO B1 claim1 requires oxycodone/naloxone ratio5:1–1:1 and approximately equal release rates; pain-treatment claim28 inherits that composition. The2017-03-28 certificate corrects claim30 from method to pharmaceutical composition. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Controlled-release oxycodone/naloxone ratio and57.4–90% naloxone release over3 hours. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Controlled-release oxycodone/naloxone5:1–1:1 composition with65.9–95.9% naloxone release over4 hours. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Oxycodone/naloxone ratio5:1–1:1 and more-than90% naloxone release over10 hours; related methods inherit composition restrictions. | Source |
| PATENT | 2022-05-10 | FTO_TAIL | Controlled-release oxycodone/naloxone ratio and45.4–78% naloxone release over2 hours. | Source |
| PATENT | 2023-04-04 | FTO_TAIL | Oxycodone/naloxone2:1 matrix with specified agonist dose, ethylcellulose1–15% and fatty alcohol10–25%. | Source |
| PATENT | 2023-04-04 | FTO_TAIL | Oxycodone/naloxone diffusion matrix containing ethylcellulose and fatty alcohol with quantitative content and invariant independent release constraints. | Source |
| PATENT | 2025-03-30 | FTO_TAIL | Oxycodone HCl with a named impurity/API ratio of0.04% or less measured byHPLC; purity and production/formulation restrictions remain. | Source |
| PATENT | 2025-03-30 | FTO_TAIL | At-least95% oxycodone HCl composition with named dihydroxy impurity and less-than25 ppm14-hydroxycodeinone, plus impurity-removal process claims. | Source |
| PATENT | 2025-03-30 | FTO_TAIL | Independent claim1 requires preparation/incubation and preferential removal of14-hydroxycodeinone; other claims address the specified salt-production/purification sequence. Not broad oxycodone chemical identity. | Source |
| PATENT | 2025-03-30 | FTO_TAIL | Oxycodone API with less-than25 ppm14-hydroxycodeinone and a specified impurity provenance. Substance quality/product-by-process limitation, not unrestricted old-active compound protection. | Source |
| PATENT | 2025-03-30 | FTO_TAIL | Oxycodone oral dosage forms with coated particles, sustained-release material and less-than25 ppm impurity sourced from a specified chemical conversion. Purity/process/formulation restrictions remain. | Source |
| REGULATORY_EXCLUSIVITY | 2017-07-23 | SCOPE_CONTEXT | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NC covers the exact oxycodone/naloxone extended-release combination at all three target strengths for severe pain requiring daily around-the-clock long-term opioid treatment when alternatives are inadequate. Abuse-deterrence study descriptions are not additional approved pain indications. | Source |
| REGULATORY_STATUS | 2018-11-28 | TERMINAL_STATUS | FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2017 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication. | 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.