VANTRELA ER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA formally withdrew approval of this NDA and all amendments/supplements on the recorded effective date; terminal status supersedes historical generic/protection facts. Current Orange Book DISCN does not capture the legal distinction; use the exact FDA withdrawal notice.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9216176 | 2027-09-13 | DP — | N | N | ABUSE_RESISTANT_OPIOID_TABLET | — | — | — |
| 9216176 | 2027-09-13 | DP — | N | N | ABUSE_RESISTANT_OPIOID_TABLET Claim 1 requires specific opioid/polymer granules, ethylcellulose/glyceryl-behenate coating and a polymer/lactose matrix, with defined weight ranges. | — | — | — |
| 9572803 | 2027-09-13 | DP — | N | N | COATED_ABUSE_RESISTANT_OPIOID_GRANULATE | — | — | — |
| 9572803 | 2027-09-13 | DP — | N | N | COATED_ABUSE_RESISTANT_OPIOID_GRANULATE Claim 1 requires opioid granulate with ethylcellulose and a specified cellulose derivative plus an ethylcellulose coating and defined content/crush-resistance limits. | — | — | — |
| 8445018 | 2029-07-31 | DP — | N | N | ABUSE_RESISTANT_OPIOID_TABLET | — | — | — |
| 8445018 | 2029-07-31 | DP — | N | N | ABUSE_RESISTANT_OPIOID_TABLET Claim 1 requires coated opioid granules with specified polymer/lipid contents and a defined tablet matrix; the claim is restricted to the abuse-resistant formulation. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 208269 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-01 | — | ALVOGEN 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 1 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 |
|---|---|---|---|---|---|---|
| 208269 / 004 | ALVOGEN INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-09-13 | FTO_TAIL | Claim 1 requires opioid granulate with ethylcellulose and a specified cellulose derivative plus an ethylcellulose coating and defined content/crush-resistance limits. | Source |
| PATENT | 2027-09-13 | FTO_TAIL | Claim 1 requires specific opioid/polymer granules, ethylcellulose/glyceryl-behenate coating and a polymer/lactose matrix, with defined weight ranges. | Source |
| PATENT | 2029-07-31 | FTO_TAIL | Claim 1 requires coated opioid granules with specified polymer/lipid contents and a defined tablet matrix; the claim is restricted to the abuse-resistant formulation. | Source |
| REGULATORY_STATUS | 2018-05-02 | TERMINAL_STATUS | FDA formally withdrew approval of this NDA and all amendments/supplements on the recorded effective date; terminal status supersedes historical generic/protection facts. Current Orange Book DISCN does not capture the legal distinction; use the exact FDA withdrawal notice. | 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.