Product profile · United States
ORLADEYO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Canonical 2035-10-07; DEEP_REVIEW; latest post-anchor right 2040-05-01; Final exact ANDA link not identified; not certified generic absence.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10329260 | 2035-03-09 | DS — | — | — | — | — | — | — |
| 10689346 | 2035-03-09 | U U-3010 | — | — | — | — | — | — |
| 11230530 | 2035-03-09 | U U-3300 | — | — | — | — | — | — |
| 11708333 | 2035-03-09 | U U-3300 | — | — | — | — | — | — |
| 12116346 | 2035-03-09 | DS — | — | — | — | — | — | — |
| 10125102 | 2035-04-07 | DS/U U-3010 | — | — | — | — | — | — |
| 10329260 | 2035-09-09 | — — | — | — | — | — | 2035-09-09 | — |
| 10329260 | 2035-09-09 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | 2035-09-09 | — |
| 10689346 | 2035-09-09 | — — | — | — | — | — | 2035-09-09 | — |
| 10689346 | 2035-09-09 | ORANGE_BOOK U-3010 | N | Y | DS_EQUIVALENT English description not available. | — | 2035-09-09 | — |
| 11230530 | 2035-09-09 | — — | — | — | — | — | 2035-09-09 | — |
| 11230530 | 2035-09-09 | ORANGE_BOOK U-3300 | N | Y | DS_EQUIVALENT English description not available. | — | 2035-09-09 | — |
| 11708333 | 2035-09-09 | — — | — | — | — | — | 2035-09-09 | — |
| 11708333 | 2035-09-09 | ORANGE_BOOK U-3300 | N | N | U English description not available. | — | 2035-09-09 | — |
| 12116346 | 2035-09-09 | — — | — | — | — | — | 2035-09-09 | — |
| 12116346 | 2035-09-09 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | 2035-09-09 | — |
| 10125102 | 2035-10-07 | — — | — | — | — | — | 2035-10-07 | — |
| 10125102 | 2035-10-07 | ORANGE_BOOK U-3010 | Y | N | TRUE_DS English description not available. | — | 2035-10-07 | — |
| 10662160 | 2039-11-01 | DS/U U-3010 | — | — | — | — | — | — |
| 11117867 | 2039-11-01 | DP/U U-3010 | — | — | — | — | — | — |
| 11618733 | 2039-11-01 | U U-3300 | — | — | — | — | — | — |
| 12344585 | 2039-11-01 | U U-3010 | — | — | — | — | — | — |
| 12545645 | 2039-11-01 | DS/DP — | — | — | — | — | — | — |
| 12545646 | 2039-11-01 | DS/DP — | — | — | — | — | — | — |
| 12545647 | 2039-11-01 | DS/DP — | — | — | — | — | — | — |
| 12552750 | 2039-11-01 | DS/DP — | — | — | — | — | — | — |
| 12590068 | 2039-11-01 | DS/DP — | — | — | — | — | — | — |
| 12590069 | 2039-11-01 | DS/DP — | — | — | — | — | — | — |
| 10662160 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 10662160 | 2040-05-01 | ORANGE_BOOK U-3010 | N | N | DP English description not available. | — | 2040-05-01 | — |
| 11117867 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 11117867 | 2040-05-01 | ORANGE_BOOK U-3010 | N | N | DP English description not available. | — | 2040-05-01 | — |
| 11618733 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 11618733 | 2040-05-01 | ORANGE_BOOK U-3300 | N | N | U English description not available. | — | 2040-05-01 | — |
| 12344585 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12344585 | 2040-05-01 | ORANGE_BOOK U-3010 | N | N | U English description not available. | — | 2040-05-01 | — |
| 12545645 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12545645 | 2040-05-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2040-05-01 | — |
| 12545646 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12545646 | 2040-05-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2040-05-01 | — |
| 12545647 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12545647 | 2040-05-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2040-05-01 | — |
| 12552750 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12552750 | 2040-05-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2040-05-01 | — |
| 12590068 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12590068 | 2040-05-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2040-05-01 | — |
| 12590069 | 2040-05-01 | — — | — | — | — | — | 2040-05-01 | — |
| 12590069 | 2040-05-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2040-05-01 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2020-12-03 | 2025-12-03 | English description not available. | Y | Y | — | Source | |
| ODE-333 | — | 2027-12-03 | — | — | — | — | Source | |
| ODE-333 | 2020-12-03 | 2027-12-03 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | Y | Y | 2027-12-03 | Source | |
| PED | — | 2028-06-03 | — | — | — | — | Source | |
| PED | 2027-12-03 | 2028-06-03 | English description not available. | Y | Y | 2028-06-03 | 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 (20)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-09-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-09-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-09-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-09-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-09-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-10-07 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-01 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2035-10-07 | CANONICAL_DECISION | Canonical 2035-10-07; DEEP_REVIEW; latest post-anchor right 2040-05-01; Final exact ANDA link not identified; not certified 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.
No litigation or settlement record currently linked to this product.