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Orange Book drug · Brand (NDA)

Abilify Mycite Kit

Aripiprazole

DiscontinuedRLDNDA 207202 6 strengths Otsuka
Approved
Nov 13, 2017
Strengths
6
Listed patents
27

What does the FDA Orange Book show for Abilify Mycite Kit?

Abilify Mycite Kit contains Aripiprazole and is the new drug FDA Orange Book record for NDA 207202. The application has 6 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 207202

New drug application identity from the Orange Book snapshot.

Application holder
Otsuka Pharmaceutical Co Ltd

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
6

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Discontinued

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
27

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0012MGTABLETORALDiscontinuedNone posted
RLD
0025MGTABLETORALDiscontinuedNone posted
RLD
00310MGTABLETORALDiscontinuedNone posted
RLD
00415MGTABLETORALDiscontinuedNone posted
RLD
00520MGTABLETORALDiscontinuedNone posted
RLD
00630MGTABLETORALDiscontinuedNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Otsuka Pharmaceutical Co Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 207202.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

6 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

26 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Oct 15, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

37 other ANDAs and 8 other NDAs found

28 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 207202 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-207202

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

6 approved presentations · NDA 207202
RLDDiscontinued
Strength
2MG
Dosage form
TABLET
Route
ORAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 10 mo ago

  2. Patent 11476952 expires

    Listed drug product patent expiration.

    3 mo ago

  3. Today

  4. Patent 9125939 expires

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

    in 2 d

  5. Patent 7978064 expires

    Listed drug product patent expiration.

    in 2 mo

  6. Patent 8759350 expires

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

    in 7 mo

  7. Patent 9444503 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  8. Patent 9119554 expires

    Listed drug product patent expiration.

    in 2 yr 5 mo

  9. Patent 9060708 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  10. Patent 9258035 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  11. Patent 8674825 expires

    Listed drug product patent expiration.

    in 2 yr 9 mo

  12. Patent 8956288 expires

    Listed drug product patent expiration.

    in 3 yr

  13. Patent 10441194 expires

    Listed drug product patent expiration.

    in 3 yr 1 mo

  14. Patent 8945005 expires

    Listed drug product patent expiration.

    in 3 yr 1 mo

  15. Patent 9433371 expires

    Listed drug product patent expiration.

    in 3 yr 2 mo

  16. Patent 8718193 expires

    Listed drug product patent expiration.

    in 3 yr 5 mo

  17. Patent 9149577 expires

    Listed drug product patent expiration.

    in 3 yr 5 mo

  18. Patent 8847766 expires

    Listed drug product patent expiration.

    in 3 yr 9 mo

  19. Patent 8545402 expires

    Listed drug product patent expiration.

    in 3 yr 10 mo

  20. Patent 8114021 expires

    Listed drug product patent expiration.

    in 4 yr

  21. Patent 11464423 expires

    Listed drug product patent expiration.

    in 4 yr 2 mo

  22. Patent 9941931 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  23. Patent 8961412 expires

    Listed drug product patent expiration.

    in 4 yr 5 mo

  24. Patent 8258962 expires

    Listed drug product patent expiration.

    in 4 yr 5 mo

  25. Patent 8547248 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  26. Patent 11229378 expires

    Listed drug product patent expiration.

    in 5 yr

  27. Patent 9320455 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  28. Patent 10517507 expires

    Listed drug product patent expiration.

    in 6 yr

  29. Patent 9268909 expires

    Listed drug product patent expiration.

    in 7 yr 4 mo

Patent & exclusivity timeline

Protection horizon
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

Pharmaceutical detail

FDA product record

Active ingredient

ARIPIPRAZOLE

Strength

2MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 207202

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
114769523 mo ago
Product
9125939in 2 d
U-1749
7978064in 2 mo
Product
8759350in 7 mo
U-1529
9444503in 1 yr 4 mo
ProductU-2169
9119554in 2 yr 5 mo
Product
9060708in 2 yr 8 mo
Product
9258035in 2 yr 8 mo
Product
8674825in 2 yr 9 mo
ProductU-2170
8956288in 3 yr
ProductU-2167
10441194in 3 yr 1 mo
Product
8945005in 3 yr 1 mo
ProductU-2167
9433371in 3 yr 2 mo
Product
8718193in 3 yr 5 mo
Product
9149577in 3 yr 5 mo
Product
8847766in 3 yr 9 mo
ProductU-2167
8545402in 3 yr 10 mo
Product
8114021in 4 yr
Product
11464423in 4 yr 2 mo
Product
9941931in 4 yr 4 mo
Product
8961412in 4 yr 5 mo
Product
8258962in 4 yr 5 mo
Product
8547248in 4 yr 6 mo
ProductU-2167
11229378in 5 yr
Product
9320455in 5 yr 6 mo
Product
10517507in 6 yr
Product
9268909in 7 yr 4 mo
ProductU-2168

Active-ingredient family

Brand + generics

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

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Abilify Mycite Kit: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 207202 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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