Assyro AI

Orange Book product · Brand (NDA)

ARISTADA INITIO KIT

ARIPIPRAZOLE LAUROXIL

Brand (NDA)NDA 209830RX ALKERMES INC

At a glance

Jun 29, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 29, 2018

    8 yr 1 mo ago

  2. Today

  3. Patent 10112903 expires

    Listed drug substance patent expiration.

    Jun 24, 2030

    in 4 yr 1 mo

  4. Patent 8796276 expires

    Listed method-of-use patent (U-543) expiration.

    Jun 24, 2030

    in 4 yr 1 mo

  5. Patent 8431576 expires

    Listed drug substance patent expiration.

    Oct 26, 2030

    in 4 yr 5 mo

  6. Patent 10688091 expires

    Listed drug product patent expiration.

    Aug 17, 2035

    in 9 yr 4 mo

  7. Patent 10849894 expires

    Listed method-of-use patent (U-543) expiration.

    Aug 17, 2035

    in 9 yr 4 mo

  8. Patent 11154552 expires

    Listed drug product patent expiration.

    Aug 17, 2035

    in 9 yr 4 mo

  9. Patent 10016415 expires

    Listed drug product patent expiration.

    Sep 08, 2035

    in 9 yr 4 mo

  10. Patent 11273158 expires

    Listed method-of-use patent (U-543) expiration.

    Apr 06, 2039

    in 13 yr

  11. Patent 12251381 expires

    Listed method-of-use patent (U-543) expiration.

    Apr 06, 2039

    in 13 yr

Pharmaceutical detail

Active ingredient

ARIPIPRAZOLE LAUROXIL

Strength

675MG/2.4ML (281.25MG/ML)

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 209830

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 (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10112903Jun 24, 2030in 4 yr 1 mo
SubstanceU-543
8796276Jun 24, 2030in 4 yr 1 mo
U-543
8431576Oct 26, 2030in 4 yr 5 mo
Substance
10688091Aug 17, 2035in 9 yr 4 mo
Product
10849894Aug 17, 2035in 9 yr 4 mo
U-543
11154552Aug 17, 2035in 9 yr 4 mo
Product
10016415Sep 08, 2035in 9 yr 4 mo
Product
11273158Apr 06, 2039in 13 yr
U-543
12251381Apr 06, 2039in 13 yr
U-543
Agent CTA Background

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