Is Abilify still available?

Yes. Abilify (NDA 021436) is listed with marketing status Prescription in the FDA Orange Book.

Does Abilify have a generic?

Yes. The Orange Book lists 37 approved generic (ANDA) applications sharing Abilify's active ingredient (Aripiprazole). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Abilify's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Abilify substitutable for its reference brand with no expected difference in clinical effect.

When do Abilify's patents expire?

The FDA Orange Book lists 2 patents against Abilify, with the last listed patent expiring Mar 02, 2027. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Abilify's FDA application number?

Abilify is approved under NDA 021436, held by Otsuka.

Orange Book product · Brand (NDA)

Abilify

Aripiprazole

Brand (NDA)NDA 021436TE ABRLD Otsuka

Approved

Nov 15, 2002

Application

Brand (NDA)

TE code

Listed patents

Abilify (Aripiprazole) is Otsuka's brand-name drug, approved by the FDA under NDA 021436 in 2002. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 37 approved generics share this drug's active ingredient. 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.
Nov 15, 2002
24 yr ago
Today
Patent 9125939 expires
Listed method-of-use patent (U-1749) expiration.
Jul 28, 2026
in 17 d
Patent 8759350 expires
Listed method-of-use patent (U-1529) expiration.
Mar 02, 2027
in 8 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

ARIPIPRAZOLE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021436

Product number

005

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 021436

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.

View full Aripiprazole 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
9125939	Jul 28, 2026	in 17 d	U-1749
8759350	Mar 02, 2027	in 8 mo	U-1529

Abilify — 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 Aripiprazole active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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