AMYVID
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Remove blanket radioactive-diagnostic EXCLUDED classification at user request. Products 001/002 are FDA Discontinued; 001 first discontinuation date/year not established, 002 FDA OB Nov 2023 DISC. This month denotes FDA status-list transition, not exact last sale or NDA withdrawal. Products 003/004 are Prescription and restored to 2027 DEEP_REVIEW using FDA OB patent date 2027-04-30. US8506929 Google term metadata 2028-05-20 conflicts with FDA OB 2027-04-30; official terminal-disclaimer/PTA record remains unverified. Not a confirmed 2028 anchor, nor a clean CANDIDATE. Current OB: two patents, zero exclusivity rows, zero florbetapir ANDA rows; exhaustive historical Final ANDA absence not established. Historical NCE 2012-04-06 to 2017-04-06; no fresh NCE inferred for 004 packaging approval. No generic commercial launch date asserted.
Patent estate
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. | ||||||||
2026-10-10 · 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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| EXCLUSIVITY | — | EXCLUSIVITY_CHECK | Current FDA OB exclusivity rows zero; historical original NCE ended 2017-04-06. No new five-year period for 004 packaging approval. Current FDA OB ANDA rows zero; exhaustive historical Final absence not established. | Source |
| PATENT | 2027-04-30 | PATENT_ANCHOR | Compound claim 1 covers styrylpyridine derivatives with radiolabel and permitted substituents. GNR existing substance review retained; FDA OB product-specific DS/DP/U-4217 date 2027-04-30. | Source |
| PATENT | 2027-04-30 | PATENT_DATE_CONFLICT | Compound claims 1-2 and composition/use claims 3-6. FDA OB 2027-04-30 vs Google adjusted date 2028-05-20; no official terminal disclaimer/PTA resolution asserted. Active products DEEP_REVIEW pending resolution. | Source |
| REGULATORY | — | PRODUCT_STATUS | FDA current product status confirmed: 001/002 Discontinued; 003/004 Prescription. Never infer exact last-sale date from approval date. | Source |
| REGULATORY | — | STATUS_EVENT | FDA December 2023 cumulative OB RX list page 1-63: 002 Nov DISC. 001 Nov CRLD is reference-list designation change, NOT a discontinuation event. 001 status year remains NULL. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2023 | DISCONTINUED | FINAL | 2027-04-30 | 2026-10-22 08:07:38 |
| N | 2012 | EXCLUDED | FINAL | 2012-04-06 | 2026-10-15 11:13:32 |
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.