Assyro AI

Orange Book product · Brand (NDA)

POSLUMA

FLOTUFOLASTAT F-18 GALLIUM

Brand (NDA)NDA 216023RX BLUE EARTH

At a glance

May 25, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

8

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 25, 2023

    3 yr 1 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    May 25, 2028

    in 2 yr

  4. Patent 12390540 expires

    Listed drug substance patent expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  5. Patent 11413360 expires

    Listed drug substance patent expiration.

    Nov 22, 2038

    in 12 yr 7 mo

  6. Patent 11413360 expires

    Listed drug substance patent expiration.

    Nov 22, 2038

    in 12 yr 7 mo

  7. Patent 12357711 expires

    Listed drug substance patent expiration.

    Nov 22, 2038

    in 12 yr 7 mo

  8. Patent 12377176 expires

    Listed drug substance patent expiration.

    Nov 22, 2038

    in 12 yr 7 mo

  9. Patent 12036290 expires

    Listed drug product patent expiration.

    Nov 27, 2041

    in 15 yr 8 mo

  10. Patent 12036290 expires

    Listed drug product patent expiration.

    Nov 27, 2041

    in 15 yr 8 mo

  11. Patent 12427207 expires

    Listed drug product patent expiration.

    Nov 27, 2041

    in 15 yr 8 mo

Pharmaceutical detail

Active ingredient

FLOTUFOLASTAT F-18 GALLIUM

Strength

25ML (8-158mCi/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216023

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    May 25, 2028

    in 2 yr

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12390540Aug 23, 2038in 12 yr 4 mo
Substance
11413360Nov 22, 2038in 12 yr 7 mo
SubstanceU-3614
11413360Nov 22, 2038in 12 yr 7 mo
SubstanceU-3615
12357711Nov 22, 2038in 12 yr 7 mo
Substance
12377176Nov 22, 2038in 12 yr 7 mo
Substance
12036290Nov 27, 2041in 15 yr 8 mo
ProductU-3614
12036290Nov 27, 2041in 15 yr 8 mo
ProductU-3615
12427207Nov 27, 2041in 15 yr 8 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.