YUTREPIA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2028. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2028-05-23. Anchor date: 2028-05-23. Patent tail: yes. Exclusivity tail: no. Review status: FINAL_CHECKING. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | — | 2028-05-23 | — | — | — | — | 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. | ||||||
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 |
|---|---|---|---|---|---|
| 2026-10-13 | United Therapeutics / Liquidia | SETTLEMENT Brand-level record; strength scope not established
|
Not disclosed | SOURCE_CONFIRMED | Source |
| tracking_id=US-N213005-UTHR-LIQUIDIA-20261013-SETTLEMENT; 합의 효력 발생과 releases 조건을 구분. PAH 판매 지속; PH-ILD 표시 삭제 신청·FDA 승인 및 지급/소취하 조건. FDA 적응증 삭제 승인 완료로 단정하지 않음. 보도자료와 SEC 본문 특허번호 불일치(11826327 대11824327,10898494 대10989494), 판결/Exhibit 원본 대조 대기.; verified source 2026-10-24. No Final approval, global legal anchor or actual launch inferred. | |||||