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Orange Book product · Brand (NDA)

Abilify Maintena Kit

Aripiprazole

Brand (NDA)NDA 202971RLD Otsuka Pharm Co Ltd
Approved
Feb 28, 2013
Application
Brand (NDA)
TE code
Not listed
Listed patents
15
Abilify Maintena Kit (Aripiprazole) is Otsuka Pharm Co Ltd's brand-name drug, approved by the FDA under NDA 202971 in 2013. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 37 approved generics share this drug's active ingredient. The FDA Orange Book lists 15 patents against it, the last expiring 2034.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 28, 2013

    13 yr 7 mo ago

  2. Today

  3. Patent 10980803 expires

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

    Sep 24, 2033

    in 7 yr 4 mo

  4. Patent 10980803 expires

    Listed method-of-use patent (U-1632) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  5. Patent 11154553 expires

    Listed method-of-use patent (U-1632) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  6. Patent 11154553 expires

    Listed method-of-use patent (U-814) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  7. Patent 11154553 expires

    Listed method-of-use patent (U-3245) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  8. Patent 11344547 expires

    Listed method-of-use patent (U-1632) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  9. Patent 11344547 expires

    Listed method-of-use patent (U-3245) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  10. Patent 11344547 expires

    Listed method-of-use patent (U-814) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  11. Patent 11400087 expires

    Listed method-of-use patent (U-3245) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  12. Patent 11400087 expires

    Listed method-of-use patent (U-814) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  13. Patent 11400087 expires

    Listed method-of-use patent (U-1632) expiration.

    Sep 24, 2033

    in 7 yr 4 mo

  14. Patent 10525057 expires

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

    Mar 08, 2034

    in 7 yr 9 mo

  15. Patent 10525057 expires

    Listed method-of-use patent (U-1632) expiration.

    Mar 08, 2034

    in 7 yr 9 mo

  16. Patent 10525057 expires

    Listed method-of-use patent (U-2723) expiration.

    Mar 08, 2034

    in 7 yr 9 mo

  17. Patent 11648347 expires

    Listed drug product patent expiration.

    Apr 06, 2034

    in 7 yr 10 mo

Protection horizon

Patent & exclusivity timeline

2026202720282029203020312032203320342035TodayPatent 10980803 — 2033-09-24Patent 10980803Patent 10980803 — 2033-09-24Patent 10980803Patent 11154553 — 2033-09-24Patent 11154553Patent 11154553 — 2033-09-24Patent 11154553Patent 11154553 — 2033-09-24Patent 11154553Patent 11344547 — 2033-09-24Patent 11344547Patent 11344547 — 2033-09-24Patent 11344547Patent 11344547 — 2033-09-24Patent 11344547Patent 11400087 — 2033-09-24Patent 11400087Patent 11400087 — 2033-09-24Patent 11400087Patent 11400087 — 2033-09-24Patent 11400087Patent 10525057 — 2034-03-08Patent 10525057Patent 10525057 — 2034-03-08Patent 10525057Patent 10525057 — 2034-03-08Patent 10525057Patent 11648347 — 2034-04-06Patent 11648347
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

ARIPIPRAZOLE

Strength

300MG/VIAL

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 202971

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 202971

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 (15)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10980803Sep 24, 2033in 7 yr 4 mo
U-543
10980803Sep 24, 2033in 7 yr 4 mo
U-1632
11154553Sep 24, 2033in 7 yr 4 mo
U-1632
11154553Sep 24, 2033in 7 yr 4 mo
U-814
11154553Sep 24, 2033in 7 yr 4 mo
U-3245
11344547Sep 24, 2033in 7 yr 4 mo
U-1632
11344547Sep 24, 2033in 7 yr 4 mo
U-3245
11344547Sep 24, 2033in 7 yr 4 mo
U-814
11400087Sep 24, 2033in 7 yr 4 mo
U-3245
11400087Sep 24, 2033in 7 yr 4 mo
U-814
11400087Sep 24, 2033in 7 yr 4 mo
U-1632
10525057Mar 08, 2034in 7 yr 9 mo
U-543
10525057Mar 08, 2034in 7 yr 9 mo
U-1632
10525057Mar 08, 2034in 7 yr 9 mo
U-2723
11648347Apr 06, 2034in 7 yr 10 mo
Product

Abilify Maintena Kit — 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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