Assyro AI

Orange Book product · Brand (NDA)

MULTRYS

CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

Brand (NDA)NDA 209376RX AM REGENT

At a glance

Jun 30, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

5

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 30, 2021

    5 yr 1 mo ago

  2. Today

  3. Patent 11786548 expires

    Listed drug product patent expiration.

    Jul 01, 2041

    in 15 yr 3 mo

  4. Patent 11975022 expires

    Listed method-of-use patent (U-3900) expiration.

    Jul 01, 2041

    in 15 yr 3 mo

  5. Patent 11998565 expires

    Listed drug product patent expiration.

    Jul 01, 2041

    in 15 yr 3 mo

  6. Patent 12150956 expires

    Listed method-of-use patent (U-3900) expiration.

    Jul 01, 2041

    in 15 yr 3 mo

  7. Patent 12150957 expires

    Listed method-of-use patent (U-3900) expiration.

    Jul 01, 2041

    in 15 yr 3 mo

Pharmaceutical detail

Active ingredient

CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

Strength

EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 209376

Product number

003

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.

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11786548Jul 01, 2041in 15 yr 3 mo
Product
11975022Jul 01, 2041in 15 yr 3 mo
U-3900
11998565Jul 01, 2041in 15 yr 3 mo
Product
12150956Jul 01, 2041in 15 yr 3 mo
U-3900
12150957Jul 01, 2041in 15 yr 3 mo
U-3900
Agent CTA Background

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