GALAFOLD
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_RIGHTS
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10383864 | 2027-05-16 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 10406143 | 2027-05-16 | U U-2371 | N | N | U | — | — | — |
| 11241422 | 2027-05-16 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 9000011 | 2027-05-16 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 9480682 | 2027-05-16 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 9987263 | 2027-05-16 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 10525045 | 2028-04-28 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 10925866 | 2028-04-28 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 11033538 | 2028-04-28 | U U-2371 | N | N | U | — | — | — |
| 12599595 | 2028-04-28 | U U-2371 | N | N | U | — | — | — |
| 9999618 | 2028-04-28 | U U-2372 | N | N | U | — | — | — |
| 9999618 | 2028-04-28 | U U-2373 | N | N | U | — | — | — |
| 10813921 | 2029-02-12 | U U-2371 | N | N | U | — | — | — |
| 8592362 | 2029-02-12 | U U-2371 | N | N | U | — | — | — |
| 9095584 | 2029-02-12 | U U-2371 | N | N | U | — | — | — |
| RE48608 | 2031-10-20 | U U-2371 | N | N | U | — | — | — |
| 12599594 | 2036-07-19 | U U-2371 | N | N | U | — | — | — |
| 10076514 | 2037-03-15 | U U-2371 | N | N | U | — | — | — |
| 11234972 | 2037-03-15 | U U-2371 | N | N | U | — | — | — |
| 10251873 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10471053 | 2038-05-30 | U U-2371 | N | Y | DS_EQUIVALENT | — | — | — |
| 10792278 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10792279 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10799491 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10806727 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10849889 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10849890 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10857141 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10857142 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10874655 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10874656 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 10874657 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11278536 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11278537 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11278538 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11278539 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11278540 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11304940 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11357761 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11357762 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11357763 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11357764 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11357765 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11376244 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11389436 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11389437 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11426396 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11458128 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11612593 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11612594 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11633387 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11666564 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 11786516 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 11813255 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 12042488 | 2038-05-30 | DS — | N | N | OTHER | — | — | — |
| 12042489 | 2038-05-30 | DS/U U-2371 | N | N | OTHER | — | — | — |
| 12042490 | 2038-05-30 | U U-2371 | N | N | U | — | — | — |
| 12109205 | 2038-05-30 | DS/U U-2371 | N | N | U | — | — | — |
| 12280042 | 2038-05-30 | DS/U U-2371 | N | N | U | — | — | — |
| 11903938 | 2038-08-17 | DS/U U-2371 | N | N | OTHER | — | — | — |
| 11357784 | 2039-02-06 | U U-2371 | N | N | U | — | — | — |
| 11826360 | 2039-02-16 | DS — | N | N | OTHER | — | — | — |
| 11642334 | 2039-02-20 | U U-2371 | N | N | U | — | — | — |
| 11622962 | 2039-03-17 | DS — | N | N | OTHER | — | — | — |
| 11633388 | 2039-03-25 | U U-2371 | N | N | U | — | — | — |
| 12594268 | 2041-05-23 | U U-2371 | N | N | U | — | — | — |
| 11833164 | 2042-01-11 | U U-2371 | N | N | U | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | — | 2023-08-10 | FDA historical NCE 5-year new chemical entity exclusivity. Active-moiety-wide protection against covered follow-on NDA/ANDA applications; not indication-specific. Statutory exceptions or waivers are not excluded by this categorization. | Y | Y | — | — | Source |
| ODE-205 | — | 2025-08-10 | Historical Orange Book exclusivity; scope and start date not independently established | — | — | — | — | Source |
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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| REGULATORY_STATUS | 2038-05-30 | CANONICAL_DECISION | POST_ANCHOR_RIGHTS | Source |
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.