Product profile · United States
ROXYBOND
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. Available oxycodone ANDAs reference ROXICODONE or older reference products; FDA letters 090895, 090659 and 202662 establish that family. None establishes a direct ROXYBOND reference. The 10 mg strength requires particular care because suitability-petition strengths can predate ROXYBOND approval. Historical regulatory exclusivity records have been recovered and scope-reviewed; absence in the current snapshot is not treated as absence of history.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10314788 | 2028-08-12 | DP — | N | N | ABUSE_DETERRENT_DOSAGE_FORM | — | — | — |
| 10314788 | 2028-08-12 | DP — | N | N | ABUSE_DETERRENT_DOSAGE_FORM Independent claims require monolithic expansion, barrier, and diffusion layers with opioid release or pharmacokinetic behavior after division. July 30, 2019 certificate corrections were checked. | — | — | — |
| 7955619 | 2028-08-12 | DP — | N | N | LAYERED_DOSAGE_FORM | — | — | — |
| 7955619 | 2028-08-12 | DP — | N | N | LAYERED_DOSAGE_FORM Independent claims require bonded barrier and drug diffusion layers; additional claims restrict expansion layers and release properties. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2017-04-20 | 2020-04-20 | Protection associated with the studied abuse-deterrent formulation and labeling; it does not establish protection of unrestricted oxycodone analgesia or the entire approved product scope. | N | N | — | 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 |
|---|---|---|---|---|---|---|---|
| 077290 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2005-12-08 | — | NESHER PHARMACEUTICALS USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076758 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2007-03-19 | — | SPECGX LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077712 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2009-03-02 | — | STRIDES PHARMA INTERNATIONAL AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090659 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2009-04-10 | — | SUN PHARMACEUTICAL INDUSTRIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090895 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2009-08-24 | — | EPIC PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091393 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2009-08-31 | — | AVANTHI INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091313 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-02-18 | — | DR REDDYS LABORATORIES SA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091490 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-03-09 | — | RHODES PHARMACEUTICALS LP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202116 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-12-30 | — | ALVOGEN INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202160 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2012-11-19 | — | AUROLIFE PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203638 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-03 | — | AMNEAL PHARMACEUTICALS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076636 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2015-04-07 | — | ACTAVIS ELIZABETH LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202662 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-22 | — | EPIC PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207119 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-04-12 | — | NUVO PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204021 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-06-12 | — | NOVEL LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207418 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-14 | — | ASCENT PHARMACEUTICALS INC | 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 16 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 |
|---|---|---|---|---|---|---|
| 077290 / 001 | NESHER PHARMACEUTICALS USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2005-12-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076758 / 003 | SPECGX LLC | FINAL_APPROVAL · FINAL_APPROVED | 2007-03-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077712 / 003 | STRIDES PHARMA INTERNATIONAL AG | FINAL_APPROVAL · FINAL_APPROVED | 2009-03-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090659 / 001 | SUN PHARMACEUTICAL INDUSTRIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2009-04-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090895 / 001 | EPIC PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2009-08-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091393 / 001 | AVANTHI INC | FINAL_APPROVAL · FINAL_APPROVED | 2009-08-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091313 / 001 | DR REDDYS LABORATORIES SA | FINAL_APPROVAL · FINAL_APPROVED | 2011-02-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091490 / 001 | RHODES PHARMACEUTICALS LP | FINAL_APPROVAL · FINAL_APPROVED | 2011-03-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202116 / 001 | ALVOGEN INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-12-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202160 / 001 | AUROLIFE PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2012-11-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203638 / 001 | AMNEAL PHARMACEUTICALS | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076636 / 003 | ACTAVIS ELIZABETH LLC | FINAL_APPROVAL · FINAL_APPROVED | 2015-04-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202662 / 001 | EPIC PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2015-09-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207119 / 001 | NUVO PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-04-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204021 / 001 | NOVEL LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-06-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207418 / 003 | ASCENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-08-12 | FTO_TAIL | Independent claims require bonded barrier and drug diffusion layers; additional claims restrict expansion layers and release properties. | Source |
| PATENT | 2028-08-12 | FTO_TAIL | Independent claims require monolithic expansion, barrier, and diffusion layers with opioid release or pharmacokinetic behavior after division. July 30, 2019 certificate corrections were checked. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Protection associated with the studied abuse-deterrent formulation and labeling; it does not establish protection of unrestricted oxycodone analgesia or the entire approved product scope. | Source |
| REGULATORY_STATUS | 2017-04-20 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. Available oxycodone ANDAs reference ROXICODONE or older reference products; FDA letters 090895, 090659 and 202662 establish that family. None establishes a direct ROXYBOND reference. The 10 mg strength requires particular care because suitability-petition strengths can predate ROXYBOND approval. Historical regulatory exclusivity records have been recovered and scope-reviewed; absence in the current snapshot is not treated as absence of history. | 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.