Product profile · United States
HETLIOZ LQ
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2035. Anchor type: PATENT. Patent anchor: 2035-08-29. Exclusivity anchor: 2027-12-01. Anchor date: 2035-08-29. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10149829 | 2033-01-25 | U U-3006 | N | N | U English description not available. | — | — | — |
| 10149829 | 2033-01-25 | ORANGE_BOOK U-3006 | N | N | U English description not available. | — | — | — |
| 10610510 | 2033-01-25 | U U-3009 | N | N | U English description not available. | — | — | — |
| 10610510 | 2033-01-25 | ORANGE_BOOK U-3009 | N | N | U English description not available. | — | — | — |
| 10980770 | 2033-01-25 | U U-3106 | N | N | U English description not available. | — | — | — |
| 10980770 | 2033-01-25 | ORANGE_BOOK U-3106 | N | N | U English description not available. | — | — | — |
| 11285129 | 2033-01-25 | U U-3342 | N | N | U English description not available. | — | — | — |
| 11285129 | 2033-01-25 | ORANGE_BOOK U-3342 | N | N | U English description not available. | — | — | — |
| 11633377 | 2033-01-25 | U U-3003 | N | N | U English description not available. | — | — | — |
| 11633377 | 2033-01-25 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
| 11826339 | 2033-01-25 | U U-3342 | N | N | U English description not available. | — | — | — |
| 11826339 | 2033-01-25 | ORANGE_BOOK U-3342 | N | N | U English description not available. | — | — | — |
| 11833130 | 2033-01-25 | U U-3003 | N | N | U English description not available. | — | — | — |
| 11833130 | 2033-01-25 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
| 11850229 | 2033-01-25 | U U-3342 | N | N | U English description not available. | — | — | — |
| 11850229 | 2033-01-25 | ORANGE_BOOK U-3342 | N | N | U English description not available. | — | — | — |
| 11918557 | 2033-01-25 | U U-3003 | N | N | U English description not available. | — | — | — |
| 11918557 | 2033-01-25 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
| 12201604 | 2033-01-25 | U U-3003 | N | N | U English description not available. | — | — | — |
| 12201604 | 2033-01-25 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
| 9539234 | 2033-01-25 | U U-3004 | N | N | U English description not available. | — | — | — |
| 9539234 | 2033-01-25 | ORANGE_BOOK U-3004 | N | N | U English description not available. | — | — | — |
| 11918556 | 2033-04-07 | U U-3342 | N | N | U English description not available. | — | — | — |
| 11918556 | 2033-04-07 | ORANGE_BOOK U-3342 | N | N | U English description not available. | — | — | — |
| 9730910 | 2034-05-17 | U U-3005 | N | N | U English description not available. | — | — | — |
| 9730910 | 2034-05-17 | ORANGE_BOOK U-3005 | N | N | U English description not available. | — | — | — |
| 10610511 | 2034-10-10 | U U-3007 | N | Y | U English description not available. | — | — | — |
| 10610511 | 2034-10-10 | ORANGE_BOOK U-3007 | N | Y | U English description not available. | — | — | — |
| 11141400 | 2034-10-10 | U U-3007 | N | N | U English description not available. | — | — | — |
| 11141400 | 2034-10-10 | ORANGE_BOOK U-3007 | N | N | U English description not available. | — | — | — |
| 11786502 | 2034-10-10 | U U-3007 | N | N | U English description not available. | — | — | — |
| 11786502 | 2034-10-10 | ORANGE_BOOK U-3007 | N | N | U English description not available. | — | — | — |
| 10071977 | 2035-02-12 | DS/DP — | N | N | PROCESS English description not available. | — | — | — |
| 10071977 | 2035-02-12 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 10829465 | 2035-02-12 | DS/DP — | N | N | PROCESS English description not available. | — | — | — |
| 10829465 | 2035-02-12 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 11566011 | 2035-02-12 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 11566011 | 2035-02-12 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11760740 | 2035-02-12 | DS/DP — | N | N | PROCESS English description not available. | — | — | — |
| 11760740 | 2035-02-12 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 12049457 | 2035-02-12 | DS/DP — | N | N | PROCESS English description not available. | — | — | — |
| 12049457 | 2035-02-12 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 10376487 | 2035-07-27 | U U-3007 | N | N | U English description not available. | — | — | — |
| 10376487 | 2035-07-27 | ORANGE_BOOK U-3007 | N | N | U English description not available. | — | — | — |
| 10179119 | 2035-08-29 | U U-3003 | N | Y | U English description not available. | — | — | — |
| 10179119 | 2035-08-29 | ORANGE_BOOK U-3003 | N | Y | U English description not available. | — | — | — |
| 11266622 | 2035-08-29 | U U-3003 | N | N | U English description not available. | — | — | — |
| 11266622 | 2035-08-29 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
| 11202770 | 2040-12-11 | DP — | N | N | DP English description not available. | — | — | — |
| 11202770 | 2040-12-11 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12447141 | 2040-12-11 | U U-3003 | N | N | U English description not available. | — | — | — |
| 12447141 | 2040-12-11 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
| 11759446 | 2041-02-21 | U U-3003 | N | N | U English description not available. | — | — | — |
| 11759446 | 2041-02-21 | ORANGE_BOOK U-3003 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2020-12-01 | 2023-12-01 | English description not available. | Y | Y | 2023-12-01 | ODE-329
Full coverage date: 2023-12-01
| Source |
| ODE-329 | 2020-12-01 | 2027-12-01 | English description not available. | Y | Y | 2027-12-01 | — | Source |
| ODE-329 | 2020-12-01 | 2027-12-01 | English description not available. | Y | Y | 2027-12-01 | ODE-329
Full coverage date: 2027-12-01
| 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 (30)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-04-07 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-05-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-10-10 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-10-10 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-10-10 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-07-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-08-29 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2035-08-29 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2040-12-11 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-12-11 | FTO_TAIL | English description not available. | Source |
| PATENT | 2041-02-21 | 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_STATUS | 2035-08-29 | CANONICAL_DECISION | English description not available. | 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 | MSN Pharmaceuticals (Vanda patent litigation) | LITIGATION Brand-level record; strength scope not established
|
Not disclosed | REPORTED | — |
| Patent litigation between Vanda and MSN regarding HETLIOZ LQ (tasimelteon oral suspension). A June 1, 2027 trial date was previously reported; it is not the filing date, a settlement date, or a generic entry authorization. Case-specific primary-source URL has not yet been entered. Litigation status and court scheduling are subject to change. Brand-level information only; do not infer a strength-specific licence, Paragraph IV certification, settlement, or actual launch. | |||||