PARICALCITOL
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA approval of this entire NDA and its strengths was withdrawn effective 2026-04-08. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
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 |
|---|---|---|---|---|---|---|---|
| 091108 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2011-07-27 | — | SANDOZ INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204910 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-17 | — | CAPLIN STERILES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206699 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-09 | — | AMNEAL PHARMACEUTICALS CO GMBH | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207692 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-10-16 | — | EPIC PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203897 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2017-11-02 | — | RISING PHARMA HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205982 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-09 | — | EUGIA PHARMA SPECIALITIES 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 6 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 |
|---|---|---|---|---|---|---|
| 091108 / 003 | SANDOZ INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-07-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204910 / 003 | CAPLIN STERILES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206699 / 003 | AMNEAL PHARMACEUTICALS CO GMBH | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207692 / 001 | EPIC PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2017-10-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203897 / 003 | RISING PHARMA HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-11-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205982 / 003 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_STATUS | 2026-04-08 | TERMINAL_STATUS | FDA approval of this entire NDA and its strengths was withdrawn effective 2026-04-08. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date. | 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.