Product profile · United States
ORENITRAM
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_RIGHTS_EXIST; US:NDA:203496:001; exact Final ANDA not verified; not proof of generic absence
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9393203 | 2026-04-27 | DP/U U-1877 | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 9393203 | 2026-04-27 | ORANGE_BOOK U-1877 | N | N | DP English description not available. | — | — | — |
| 7417070 | 2026-07-30 | DS — | N | Y | U | B1C03P8 issued-claim review2026-10-15: U | — | — | — |
| 7417070 | 2026-07-30 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 11723887 | 2028-12-15 | DS — | N | N | OTHER | B1C03P8 issued-claim review2026-10-15: OTHER | — | — | — |
| 11723887 | 2028-12-15 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 9593066 | 2028-12-15 | DS — | N | N | OTHER | B1C03P8 issued-claim review2026-10-15: OTHER | — | — | — |
| 9593066 | 2028-12-15 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 9604901 | 2028-12-15 | DS — | N | N | OTHER | B1C03P8 issued-claim review2026-10-15: OTHER | — | — | — |
| 9604901 | 2028-12-15 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 8410169 | 2030-02-13 | DP — | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 8410169 | 2030-02-13 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8349892 | 2031-01-22 | DP — | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 8349892 | 2031-01-22 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8747897 | 2031-08-11 | DP/U U-2724 | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 8747897 | 2031-08-11 | DP/U U-2725 | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 8747897 | 2031-08-11 | ORANGE_BOOK U-2724;U-2725 | N | N | DP English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NDF | 2013-12-20 | 2016-12-20 | English description not available. | Y | Y | 2016-12-20 | ODE-308 + ODE-272
Full coverage date: 2016-12-20
| Source |
| D-156 | 2016-01-28 | 2019-01-28 | English description not available. | N | N | — | ODE-308 + ODE-272
Full coverage date: —
| Source |
| D-157 | 2016-01-28 | 2019-01-28 | English description not available. | N | N | — | ODE-308 + ODE-272
Full coverage date: —
| Source |
| ODE-308 | 2013-12-20 | 2020-12-20 | English description not available. | N | N | — | ODE-308 + ODE-272
Full coverage date: —
| Source |
| I-820 | 2019-10-18 | 2022-10-18 | English description not available. | N | N | — | ODE-308 + ODE-272
Full coverage date: —
| Source |
| ODE-272 | 2019-10-18 | 2026-10-18 | English description not available. | N | N | — | — | Source |
| ODE-272 | 2019-10-18 | 2026-10-18 | English description not available. | N | N | — | ODE-308 + ODE-272
Full coverage date: —
| Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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 2 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.
| Challenger / ANDA | Event | Lawsuit filed | Dismissal | Announcement | Settlement entry | Approval | Evidence |
|---|---|---|---|---|---|---|---|
| ANI Pharmaceuticals, Inc. / | PARAGRAPH_IV | — | — | — | — | NOT_ESTABLISHED | SOURCE_DOCUMENTED |
| ANI P4 notice February 2021; infringement lawsuit April 2021; settlement May 2022. Permitted market entry December 2027 or earlier under conditions. Exact dates and ANI ANDA number not established; FDA final approval not inferred. | |||||||
| Actavis Laboratories FL, Inc. / | PARAGRAPH_IV | — | — | — | — | NOT_ESTABLISHED | SOURCE_DOCUMENTED |
| United Therapeutics confirms Actavis ANDA litigation and settlement, market entry beginning June 2027 or earlier under conditions. Day NOT established. ANDA number NOT established for Actavis. FDA final approval not inferred. | |||||||
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|
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 (15)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-04-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-07-30 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2028-12-15 | FTO_TAIL | English description not available. | Source |
| PATENT | 2028-12-15 | FTO_TAIL | English description not available. | Source |
| PATENT | 2028-12-15 | FTO_TAIL | English description not available. | Source |
| PATENT | 2030-02-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2031-01-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2031-08-11 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | CANONICAL_ANCHOR | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | CANONICAL_ANCHOR | English description not available. | Source |
| REGULATORY_STATUS | 2026-10-18 | CANONICAL_DECISION | POST_ANCHOR_RIGHTS_EXIST; US:NDA:203496:001; exact Final ANDA not verified; not proof of generic absence | 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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| Not disclosed | ANI Pharmaceuticals, Inc. | SETTLEMENT Other product (master ID 1358); not evidence for this strength
|
2027-12 | SOURCE_DOCUMENTED | Source |
| Agreement in May 2022 permits generic entry December 2027, potentially earlier under conditions. Exact agreement date and entry day not established. No FDA final approval inferred. | |||||
| Not disclosed | Actavis Laboratories FL, Inc. | SETTLEMENT Other product (master ID 1358); not evidence for this strength
|
2027-06 | SOURCE_DOCUMENTED | Source |
| Agreement permits generic entry beginning June 2027, potentially earlier under specified circumstances. Exact calendar day and settlement execution date not verified. No FDA final approval inferred. | |||||
| Not disclosed | ANI Pharmaceuticals, Inc. | SETTLEMENT Other product (master ID 1357); not evidence for this strength
|
2027-12 | SOURCE_DOCUMENTED | Source |
| Agreement in May 2022 permits generic entry December 2027, potentially earlier under conditions. Exact agreement date and entry day not established. No FDA final approval inferred. | |||||
| Not disclosed | Actavis Laboratories FL, Inc. | SETTLEMENT Other product (master ID 1357); not evidence for this strength
|
2027-06 | SOURCE_DOCUMENTED | Source |
| Agreement permits generic entry beginning June 2027, potentially earlier under specified circumstances. Exact calendar day and settlement execution date not verified. No FDA final approval inferred. | |||||
| Not disclosed | ANI Pharmaceuticals, Inc. | SETTLEMENT Other product (master ID 1356); not evidence for this strength
|
2027-12 | SOURCE_DOCUMENTED | Source |
| Agreement in May 2022 permits generic entry December 2027, potentially earlier under conditions. Exact agreement date and entry day not established. No FDA final approval inferred. | |||||
| Not disclosed | Actavis Laboratories FL, Inc. | SETTLEMENT Other product (master ID 1356); not evidence for this strength
|
2027-06 | SOURCE_DOCUMENTED | Source |
| Agreement permits generic entry beginning June 2027, potentially earlier under specified circumstances. Exact calendar day and settlement execution date not verified. No FDA final approval inferred. | |||||
| Not disclosed | ANI Pharmaceuticals, Inc. | SETTLEMENT Other product (master ID 1355); not evidence for this strength
|
2027-12 | SOURCE_DOCUMENTED | Source |
| Agreement in May 2022 permits generic entry December 2027, potentially earlier under conditions. Exact agreement date and entry day not established. No FDA final approval inferred. | |||||
| Not disclosed | Actavis Laboratories FL, Inc. | SETTLEMENT Other product (master ID 1355); not evidence for this strength
|
2027-06 | SOURCE_DOCUMENTED | Source |
| Agreement permits generic entry beginning June 2027, potentially earlier under specified circumstances. Exact calendar day and settlement execution date not verified. No FDA final approval inferred. | |||||
| Not disclosed | ANI Pharmaceuticals, Inc. | SETTLEMENT | 2027-12 | SOURCE_DOCUMENTED | Source |
| Agreement in May 2022 permits generic entry December 2027, potentially earlier under conditions. Exact agreement date and entry day not established. No FDA final approval inferred. | |||||
| Not disclosed | Actavis Laboratories FL, Inc. | SETTLEMENT | 2027-06 | SOURCE_DOCUMENTED | Source |
| Agreement permits generic entry beginning June 2027, potentially earlier under specified circumstances. Exact calendar day and settlement execution date not verified. No FDA final approval inferred. | |||||