Assyro AI

Orange Book product · Brand (NDA)

BARHEMSYS

AMISULPRIDE

Brand (NDA)NDA 209510RX ACACIA
View AMISULPRIDE familyOpen on FDA Orange Book

At a glance

Feb 26, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

16

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 26, 2020

    6 yr 5 mo ago

  2. Today

  3. Patent 10525033 expires

    Listed drug product patent expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  4. Patent 12194022 expires

    Listed method-of-use patent (U-1744) expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  5. Patent 12194022 expires

    Listed method-of-use patent (U-3467) expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  6. Patent 9545426 expires

    Listed method-of-use patent (U-1744) expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  7. Patent 9545426 expires

    Listed method-of-use patent (U-2754) expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  8. Patent 9889118 expires

    Listed method-of-use patent (U-2754) expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  9. Patent 9889118 expires

    Listed method-of-use patent (U-1744) expiration.

    Mar 10, 2031

    in 4 yr 10 mo

  10. Patent 9084765 expires

    Listed method-of-use patent (U-1744) expiration.

    Feb 26, 2034

    in 7 yr 10 mo

  11. Patent 9084765 expires

    Listed method-of-use patent (U-2754) expiration.

    Feb 26, 2034

    in 7 yr 10 mo

  12. Patent 9084765 expires

    Listed method-of-use patent (U-3467) expiration.

    Feb 26, 2034

    in 7 yr 10 mo

  13. Patent 11357753 expires

    Listed method-of-use patent (U-2754) expiration.

    Feb 09, 2038

    in 11 yr 10 mo

  14. Patent 12005042 expires

    Listed method-of-use patent (U-1744) expiration.

    Feb 09, 2038

    in 11 yr 10 mo

  15. Patent 12005042 expires

    Listed method-of-use patent (U-3467) expiration.

    Feb 09, 2038

    in 11 yr 10 mo

  16. Patent 12005042 expires

    Listed method-of-use patent (U-2754) expiration.

    Feb 09, 2038

    in 11 yr 10 mo

  17. Patent 12329740 expires

    Listed method-of-use patent (U-2754) expiration.

    Feb 09, 2038

    in 11 yr 10 mo

  18. Patent 12329740 expires

    Listed method-of-use patent (U-3467) expiration.

    Feb 09, 2038

    in 11 yr 10 mo

Pharmaceutical detail

Active ingredient

AMISULPRIDE

Strength

5MG/2ML (2.5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 209510

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.

Listed patents (16)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10525033Mar 10, 2031in 4 yr 10 mo
Product
12194022Mar 10, 2031in 4 yr 10 mo
U-1744
12194022Mar 10, 2031in 4 yr 10 mo
U-3467
9545426Mar 10, 2031in 4 yr 10 mo
U-1744
9545426Mar 10, 2031in 4 yr 10 mo
U-2754
9889118Mar 10, 2031in 4 yr 10 mo
U-2754
9889118Mar 10, 2031in 4 yr 10 mo
U-1744
9084765Feb 26, 2034in 7 yr 10 mo
U-1744
9084765Feb 26, 2034in 7 yr 10 mo
U-2754
9084765Feb 26, 2034in 7 yr 10 mo
U-3467
11357753Feb 09, 2038in 11 yr 10 mo
U-2754
12005042Feb 09, 2038in 11 yr 10 mo
U-1744
12005042Feb 09, 2038in 11 yr 10 mo
U-3467
12005042Feb 09, 2038in 11 yr 10 mo
U-2754
12329740Feb 09, 2038in 11 yr 10 mo
U-2754
12329740Feb 09, 2038in 11 yr 10 mo
U-3467
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