Product profile · United States
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· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US9694018 c1/11 covers ALGS/PFIC; age/strength/form unrestricted. Hydrate/particle/PFIC tails retained.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10011633 | 2031-11-08 | U U-3648 | N | Y | U English description not available. | — | — | — |
| 10011633 | 2031-11-08 | U U-3186 | N | Y | U English description not available. | — | — | — |
| 10011633 | 2031-11-08 | ORANGE_BOOK U-3186;U-3648 | N | Y | U English description not available. | — | — | — |
| 10093697 | 2031-11-08 | U U-3648 | N | Y | U English description not available. | — | — | — |
| 10093697 | 2031-11-08 | U U-3186 | N | Y | U English description not available. | — | — | — |
| 10093697 | 2031-11-08 | ORANGE_BOOK U-3186;U-3648 | N | Y | U English description not available. | — | — | — |
| 10487111 | 2031-11-08 | U U-3648 | N | Y | U English description not available. | — | — | — |
| 10487111 | 2031-11-08 | U U-3186 | N | Y | U English description not available. | — | — | — |
| 10487111 | 2031-11-08 | ORANGE_BOOK U-3186;U-3648 | N | Y | U English description not available. | — | — | — |
| 10981952 | 2031-11-08 | U U-3648 | N | N | U English description not available. | — | — | — |
| 10981952 | 2031-11-08 | U U-3187 | N | N | U English description not available. | — | — | — |
| 10981952 | 2031-11-08 | U U-3649 | N | N | U English description not available. | — | — | — |
| 10981952 | 2031-11-08 | U U-3186 | N | N | U English description not available. | — | — | — |
| 10981952 | 2031-11-08 | ORANGE_BOOK U-3186;U-3187;U-3648;U-3649 | N | N | U English description not available. | — | — | — |
| 11732006 | 2031-11-08 | U U-3186 | N | Y | U English description not available. | — | — | — |
| 11732006 | 2031-11-08 | U U-3648 | N | Y | U English description not available. | — | — | — |
| 11732006 | 2031-11-08 | ORANGE_BOOK U-3186;U-3648 | N | Y | U English description not available. | — | — | — |
| 12187812 | 2031-11-08 | U U-3648 | N | N | U English description not available. | — | — | — |
| 12187812 | 2031-11-08 | U U-3186 | N | N | U English description not available. | — | — | — |
| 12187812 | 2031-11-08 | ORANGE_BOOK U-3186;U-3648 | N | N | U English description not available. | — | — | — |
| 12545705 | 2031-11-08 | U U-3186 | N | N | U English description not available. | — | — | — |
| 12545705 | 2031-11-08 | U U-3648 | N | N | U English description not available. | — | — | — |
| 12545705 | 2031-11-08 | ORANGE_BOOK U-3186;U-3648 | N | N | U English description not available. | — | — | — |
| 9694018 | 2034-03-18 | U U-3186 | N | Y | U English description not available. | — | — | — |
| 9694018 | 2034-03-18 | U U-3648 | N | Y | U English description not available. | — | — | — |
| 9694018 | 2034-03-18 | ORANGE_BOOK U-3186;U-3648 | N | Y | U English description not available. | — | — | — |
| 10975046 | 2039-06-20 | DS — | N | N | DP English description not available. | — | — | — |
| 10975046 | 2039-06-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11365182 | 2039-06-20 | U U-3186 | N | N | U English description not available. | — | — | — |
| 11365182 | 2039-06-20 | U U-3648 | N | N | U English description not available. | — | — | — |
| 11365182 | 2039-06-20 | ORANGE_BOOK U-3186;U-3648 | N | N | U English description not available. | — | — | — |
| 11801226 | 2039-06-20 | DP — | N | N | DP English description not available. | — | — | — |
| 11801226 | 2039-06-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11802115 | 2039-06-20 | DP — | N | N | DP English description not available. | — | — | — |
| 11802115 | 2039-06-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12091394 | 2039-06-20 | DS — | N | N | PROCESS English description not available. | — | — | — |
| 12091394 | 2039-06-20 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 12508234 | 2039-06-20 | U U-3648 | N | N | U English description not available. | — | — | — |
| 12508234 | 2039-06-20 | U U-3186 | N | N | U English description not available. | — | — | — |
| 12508234 | 2039-06-20 | ORANGE_BOOK U-3186;U-3648 | N | N | U English description not available. | — | — | — |
| 11583539 | 2041-11-12 | U U-3186 | N | N | U English description not available. | — | — | — |
| 11583539 | 2041-11-12 | ORANGE_BOOK U-3186 | N | N | U English description not available. | — | — | — |
| 12447156 | 2041-11-12 | U U-3186 | N | N | U English description not available. | — | — | — |
| 12447156 | 2041-11-12 | ORANGE_BOOK U-3186 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-918 | 2023-06-13 | 2026-06-13 | English description not available. | N | N | — | — | Source |
| I-918 | 2023-06-13 | 2026-06-13 | English description not available. | N | N | — | ODE-363 + ODE-436
Full coverage date: —
| Source |
| NCE | 2021-07-20 | 2026-07-20 | English description not available. | Y | Y | 2026-07-20 | — | Source |
| NCE | 2021-07-20 | 2026-07-20 | English description not available. | Y | Y | 2026-07-20 | ODE-363 + ODE-436
Full coverage date: 2026-07-20
| Source |
| ODE-363 | 2021-07-20 | 2028-07-20 | English description not available. | N | N | — | — | Source |
| ODE-363 | 2021-07-20 | 2028-07-20 | English description not available. | N | N | — | ODE-363 + ODE-436
Full coverage date: —
| Source |
| ODE-436 | 2023-06-13 | 2030-06-13 | English description not available. | N | N | — | — | Source |
| ODE-436 | 2023-06-13 | 2030-06-13 | English description not available. | N | N | — | ODE-363 + ODE-436
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 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 (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US9694018 c1/11 covers ALGS/PFIC; age/strength/form unrestricted. Hydrate/particle/PFIC tails retained. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-03-18 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-03-18 | 2026-10-15 05:56:56 |
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.