Product profile · United States
OCALIVA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA withdrew approval of NDA 207999 effective November 24, 2025. This supersedes the Orange Book discontinued classification. FDA withdrew approval of NDA 207999 effective November 24, 2025. This supersedes the Orange Book discontinued classification.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| RE48286 | 2027-02-21 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| RE48286 | 2027-02-21 | DS/DP — | Y | Y | TRUE_DS Live reissue claim 1 covers the obeticholic acid structure and specified acceptable salts/conjugates without a crystal, particle-size or manufacturing restriction. Listed expiry is retained; the PDF includes a terminal disclaimer. | — | — | — |
| 10174073 | 2033-06-17 | DS — | N | N | PRODUCT_BY_PROCESS | — | — | — |
| 10174073 | 2033-06-17 | DS — | N | N | PRODUCT_BY_PROCESS Claim 1 requires noncrystalline low-CDCA obeticholic acid prepared by organic-solvent crystallization of crude OCA. | — | — | — |
| 9238673 | 2033-06-17 | DP — | N | N | FORM_AND_PURITY_COMPOSITION | — | — | — |
| 9238673 | 2033-06-17 | DP — | N | N | FORM_AND_PURITY_COMPOSITION Claim 1 requires obeticholic acid Form 1 with a specified CDCA impurity limit and a carrier. | — | — | — |
| 10047117 | 2033-09-06 | U U-1854 | N | N | QUALITY_AND_DOSE_RESTRICTED_USE | — | — | — |
| 10047117 | 2033-09-06 | U U-1854 | N | N | QUALITY_AND_DOSE_RESTRICTED_USE Claim 1 restricts FXR-mediated disease treatment to low-CDCA-purity solid obeticholic acid at a specified dose range. | — | — | — |
| 10052337 | 2036-04-26 | DP — | N | N | PARTICLE_TABLET_FORMULATION | — | — | — |
| 10052337 | 2036-04-26 | DP — | N | N | PARTICLE_TABLET_FORMULATION Independent claims restrict obeticholic acid particle size, jet milling, excipient attributes or intragranular/extragranular tablet construction. | — | — | — |
| 10751349 | 2036-04-26 | DP — | N | N | PARTICLE_TABLET_FORMULATION | — | — | — |
| 10751349 | 2036-04-26 | DP — | N | N | PARTICLE_TABLET_FORMULATION Independent claims restrict obeticholic acid particle size, jet milling, excipient attributes or intragranular/extragranular tablet construction. | — | — | — |
| 10758549 | 2036-04-26 | U U-2945 | N | N | FORMULATION_RESTRICTED_USE | — | — | — |
| 10758549 | 2036-04-26 | U U-2945 | N | N | FORMULATION_RESTRICTED_USE Claim 1 requires primary biliary cholangitis treatment with a specified intragranular/extragranular tablet and excipient alcohol-content restriction. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-11 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 214935 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | OPTIMUS PHARMA PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214862 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-30 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214980 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-30 | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215017 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-30 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 3 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 |
|---|---|---|---|---|---|---|
| 214862 / 002 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214980 / 002 | LUPIN LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215017 / 002 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (8)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-02-21 | CANONICAL_ANCHOR | Live reissue claim 1 covers the obeticholic acid structure and specified acceptable salts/conjugates without a crystal, particle-size or manufacturing restriction. Listed expiry is retained; the PDF includes a terminal disclaimer. | Source |
| PATENT | 2033-06-17 | FTO_TAIL | Claim 1 requires noncrystalline low-CDCA obeticholic acid prepared by organic-solvent crystallization of crude OCA. | Source |
| PATENT | 2033-06-17 | FTO_TAIL | Claim 1 requires obeticholic acid Form 1 with a specified CDCA impurity limit and a carrier. | Source |
| PATENT | 2033-09-06 | FTO_TAIL | Claim 1 restricts FXR-mediated disease treatment to low-CDCA-purity solid obeticholic acid at a specified dose range. | Source |
| PATENT | 2036-04-26 | FTO_TAIL | Independent claims restrict obeticholic acid particle size, jet milling, excipient attributes or intragranular/extragranular tablet construction. | Source |
| PATENT | 2036-04-26 | FTO_TAIL | Claim 1 requires primary biliary cholangitis treatment with a specified intragranular/extragranular tablet and excipient alcohol-content restriction. | Source |
| PATENT | 2036-04-26 | FTO_TAIL | Independent claims restrict obeticholic acid particle size, jet milling, excipient attributes or intragranular/extragranular tablet construction. | Source |
| REGULATORY_STATUS | 2025-11-24 | TERMINAL_STATUS | FDA withdrew approval of NDA 207999 effective November 24, 2025. This supersedes the Orange Book discontinued classification. FDA withdrew approval of NDA 207999 effective November 24, 2025. This supersedes the Orange Book discontinued classification. | 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.