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Orange Book product · Brand (NDA)

Abilify Mycite Kit

Aripiprazole

Brand (NDA)NDA 207202DiscontinuedRLD Otsuka
Approved
Nov 13, 2017
Application
Brand (NDA)
TE code
Not listed
Listed patents
27
Abilify Mycite Kit (Aripiprazole) is Otsuka's brand-name drug, approved by the FDA under NDA 207202 in 2017. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 37 approved generics share this drug's active ingredient. The FDA Orange Book lists 27 patents against it, the last expiring 2033.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 13, 2017

    8 yr 9 mo ago

  2. Patent 11476952 expires

    Listed drug product patent expiration.

    Apr 28, 2026

    3 mo ago

  3. Today

  4. Patent 9125939 expires

    Listed method-of-use patent (U-1749) expiration.

    Jul 28, 2026

    in 16 d

  5. Patent 7978064 expires

    Listed drug product patent expiration.

    Sep 14, 2026

    in 2 mo

  6. Patent 8759350 expires

    Listed method-of-use patent (U-1529) expiration.

    Mar 02, 2027

    in 8 mo

  7. Patent 9444503 expires

    Listed drug product patent expiration.

    Nov 19, 2027

    in 1 yr 5 mo

  8. Patent 9119554 expires

    Listed drug product patent expiration.

    Dec 16, 2028

    in 2 yr 6 mo

  9. Patent 9060708 expires

    Listed drug product patent expiration.

    Mar 05, 2029

    in 2 yr 8 mo

  10. Patent 9258035 expires

    Listed drug product patent expiration.

    Mar 05, 2029

    in 2 yr 8 mo

  11. Patent 8674825 expires

    Listed drug product patent expiration.

    Apr 09, 2029

    in 2 yr 9 mo

  12. Patent 8956288 expires

    Listed drug product patent expiration.

    Jul 06, 2029

    in 3 yr

  13. Patent 10441194 expires

    Listed drug product patent expiration.

    Jul 26, 2029

    in 3 yr 1 mo

  14. Patent 8945005 expires

    Listed drug product patent expiration.

    Aug 19, 2029

    in 3 yr 2 mo

  15. Patent 9433371 expires

    Listed drug product patent expiration.

    Sep 15, 2029

    in 3 yr 3 mo

  16. Patent 8718193 expires

    Listed drug product patent expiration.

    Dec 05, 2029

    in 3 yr 5 mo

  17. Patent 9149577 expires

    Listed drug product patent expiration.

    Dec 15, 2029

    in 3 yr 6 mo

  18. Patent 8847766 expires

    Listed drug product patent expiration.

    Mar 29, 2030

    in 3 yr 9 mo

  19. Patent 8545402 expires

    Listed drug product patent expiration.

    Apr 27, 2030

    in 3 yr 10 mo

  20. Patent 8114021 expires

    Listed drug product patent expiration.

    Jun 21, 2030

    in 4 yr

  21. Patent 11464423 expires

    Listed drug product patent expiration.

    Sep 15, 2030

    in 4 yr 3 mo

  22. Patent 9941931 expires

    Listed drug product patent expiration.

    Nov 04, 2030

    in 4 yr 5 mo

  23. Patent 8961412 expires

    Listed drug product patent expiration.

    Nov 17, 2030

    in 4 yr 5 mo

  24. Patent 8258962 expires

    Listed drug product patent expiration.

    Nov 25, 2030

    in 4 yr 5 mo

  25. Patent 8547248 expires

    Listed drug product patent expiration.

    Dec 18, 2030

    in 4 yr 6 mo

  26. Patent 11229378 expires

    Listed drug product patent expiration.

    Jul 11, 2031

    in 5 yr 1 mo

  27. Patent 9320455 expires

    Listed drug product patent expiration.

    Dec 15, 2031

    in 5 yr 6 mo

  28. Patent 10517507 expires

    Listed drug product patent expiration.

    Jun 13, 2032

    in 6 yr

  29. Patent 9268909 expires

    Listed drug product patent expiration.

    Oct 15, 2033

    in 7 yr 4 mo

Protection horizon

Patent & exclusivity timeline

202620272028202920302031203220332034TodayPatent 11476952 — 2026-04-28Patent 11476952Patent 9125939 — 2026-07-28Patent 9125939Patent 7978064 — 2026-09-14Patent 7978064Patent 8759350 — 2027-03-02Patent 8759350Patent 9444503 — 2027-11-19Patent 9444503Patent 9119554 — 2028-12-16Patent 9119554Patent 9060708 — 2029-03-05Patent 9060708Patent 9258035 — 2029-03-05Patent 9258035Patent 8674825 — 2029-04-09Patent 8674825Patent 8956288 — 2029-07-06Patent 8956288Patent 10441194 — 2029-07-26Patent 10441194Patent 8945005 — 2029-08-19Patent 8945005Patent 9433371 — 2029-09-15Patent 9433371Patent 8718193 — 2029-12-05Patent 8718193Patent 9149577 — 2029-12-15Patent 9149577Patent 8847766 — 2030-03-29Patent 8847766Patent 8545402 — 2030-04-27Patent 8545402Patent 8114021 — 2030-06-21Patent 8114021Patent 11464423 — 2030-09-15Patent 11464423Patent 9941931 — 2030-11-04Patent 9941931Patent 8961412 — 2030-11-17Patent 8961412Patent 8258962 — 2030-11-25Patent 8258962Patent 8547248 — 2030-12-18Patent 8547248Patent 11229378 — 2031-07-11Patent 11229378Patent 9320455 — 2031-12-15Patent 9320455Patent 10517507 — 2032-06-13Patent 10517507Patent 9268909 — 2033-10-15Patent 9268909
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

ARIPIPRAZOLE

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 207202

Product number

005

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 207202

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 (27)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11476952Apr 28, 20263 mo ago
Product
9125939Jul 28, 2026in 16 d
U-1749
7978064Sep 14, 2026in 2 mo
Product
8759350Mar 02, 2027in 8 mo
U-1529
9444503Nov 19, 2027in 1 yr 5 mo
ProductU-2169
9119554Dec 16, 2028in 2 yr 6 mo
Product
9060708Mar 05, 2029in 2 yr 8 mo
Product
9258035Mar 05, 2029in 2 yr 8 mo
Product
8674825Apr 09, 2029in 2 yr 9 mo
ProductU-2170
8956288Jul 06, 2029in 3 yr
ProductU-2167
10441194Jul 26, 2029in 3 yr 1 mo
Product
8945005Aug 19, 2029in 3 yr 2 mo
ProductU-2167
9433371Sep 15, 2029in 3 yr 3 mo
Product
8718193Dec 05, 2029in 3 yr 5 mo
Product
9149577Dec 15, 2029in 3 yr 6 mo
Product
8847766Mar 29, 2030in 3 yr 9 mo
ProductU-2167
8545402Apr 27, 2030in 3 yr 10 mo
Product
8114021Jun 21, 2030in 4 yr
Product
11464423Sep 15, 2030in 4 yr 3 mo
Product
9941931Nov 04, 2030in 4 yr 5 mo
Product
8961412Nov 17, 2030in 4 yr 5 mo
Product
8258962Nov 25, 2030in 4 yr 5 mo
Product
8547248Dec 18, 2030in 4 yr 6 mo
ProductU-2167
11229378Jul 11, 2031in 5 yr 1 mo
Product
9320455Dec 15, 2031in 5 yr 6 mo
Product
10517507Jun 13, 2032in 6 yr
Product
9268909Oct 15, 2033in 7 yr 4 mo
ProductU-2168

Abilify Mycite 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.

Related FDA reference tools

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