Product profile · United States

AMYVID

· Patent Litigation & Settlement History ↓

IngredientFLORBETAPIR F-18

Application typeNDA

Application202008

Product001

Dosage formSOLUTION

RouteINTRAVENOUS

Strength10ML (13.5-51mCi/ML)

Approval date2012-04-06

Marketing statusDiscontinued

Status event—

ApplicantAVID RADIOPHARMS INC

Product source

Current GenericRadar decision

Year—

SelectionDISCONTINUED

ReviewFINAL

Anchor typePATENT

Anchor date2027-04-30

Patent anchor2027-04-30

Exclusivity anchor2017-04-06

Protection date2027-04-30

First Final ANDA—

Status event—

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

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7687052	2027-04-30	DS/DP/U U-4217	—	—	—	—	—	—
8506929	2027-04-30	DS/DP/U U-4217	—	—	—	—	—	—

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	—	DISCONTINUED	FINAL	2027-04-30	2026-10-22 08:07:38
N	2012	EXCLUDED	FINAL	2012-04-06	2026-10-15 11:13:32

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.