Is Amyvid still available?

Amyvid (NDA 202008) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Amyvid have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Amyvid's active ingredient (Florbetapir F-18).

When do Amyvid's patents expire?

The FDA Orange Book lists 2 patents against Amyvid, with the last listed patent expiring Apr 30, 2027. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Amyvid's FDA application number?

Amyvid is approved under NDA 202008, held by Avid Radiopharms Inc.

Orange Book product · Brand (NDA)

Amyvid

Florbetapir F-18

Brand (NDA)NDA 202008DiscontinuedRLD Avid Radiopharms Inc

Approved

Apr 06, 2012

Application

Brand (NDA)

TE code

Not listed

Listed patents

Amyvid (Florbetapir F-18) is Avid Radiopharms Inc's brand-name drug, approved by the FDA under NDA 202008 in 2012. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. The FDA Orange Book lists 2 patents against it, the last expiring 2027.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Apr 06, 2012
14 yr 6 mo ago
Today
Patent 7687052 expires
Listed drug substance patent expiration.
Apr 30, 2027
in 10 mo
Patent 8506929 expires
Listed drug substance patent expiration.
Apr 30, 2027
in 10 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

FLORBETAPIR F-18

Strength

10ML (13.5-51mCi/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 202008

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 202008

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Florbetapir F-18 family

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7687052	Apr 30, 2027	in 10 mo	SubstanceProductU-4217
8506929	Apr 30, 2027	in 10 mo	SubstanceProductU-4217

Amyvid — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Florbetapir F-18 active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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