EXALGO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2012 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5702725 | 2014-07-07 | DP/U U-1043 | N | N | DP Hydromorphone formulation with polyalkylene oxide and polyvinylpyrrolidone; prior issued-claim review reused within seven days. | — | — | — |
| US5914131 | 2014-07-07 | DP/U U-1043 | N | N | DP Osmotic layered sustained-release hydromorphone dosage form; prior issued-claim review reused within seven days. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NDF | 2010-03-01 | 2013-03-01 | NDF expires 2013-03-01, measured from original EXALGO approval 2010-03-01, not the 32 mg approval 2012-08-24. Historical listing on the exact 32 mg row is retained. Matching the sole pain indication is insufficient to prove that the original NDF studies protect the later strength in its entirety; no full-strength anchor is promoted. | N | N | — | 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 (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2014-07-07 | FTO_TAIL | Hydromorphone formulation with polyalkylene oxide and polyvinylpyrrolidone; prior issued-claim review reused within seven days. | Source |
| PATENT | 2014-07-07 | FTO_TAIL | Osmotic layered sustained-release hydromorphone dosage form; prior issued-claim review reused within seven days. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | NDF expires 2013-03-01, measured from original EXALGO approval 2010-03-01, not the 32 mg approval 2012-08-24. Historical listing on the exact 32 mg row is retained. Matching the sole pain indication is insufficient to prove that the original NDF studies protect the later strength in its entirety; no full-strength anchor is promoted. | Source |
| REGULATORY_STATUS | 2020-02-07 | TERMINAL_STATUS | FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2012 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. | 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.