FDA Orange Book

Generic for Abilify Mycite Kit

Abilify Mycite Kit contains aripiprazole. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Abilify Mycite Kit is aripiprazole. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Abilify Mycite Kit products in the Orange Book

Abilify Mycite Kit products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral10MGDiscontinuedNone14AB
tablet, oral15MGDiscontinuedNone13AB
tablet, oral20MGDiscontinuedNone13AB
tablet, oral2MGDiscontinuedNone14AB
tablet, oral30MGDiscontinuedNone13AB
tablet, oral5MGDiscontinuedNone14AB

NDA 207202, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic aripiprazole

Approved generic versions of Abilify Mycite Kit
CompanyANDATE codeApprovedStrengths
ALEMBIC PHARMACEUTICALS LTD202101AB (A-rated, therapeutically equivalent)April 28, 201510MG, 15MG, 20MG, 2MG, 30MG, 5MG
HETERO LABS LTD UNIT V205064AB (A-rated, therapeutically equivalent)April 28, 201510MG, 15MG, 20MG, 2MG, 30MG, 5MG
TORRENT PHARMACEUTICALS LTD201519AB (A-rated, therapeutically equivalent)April 28, 201510MG, 15MG, 20MG, 2MG, 30MG, 5MG
AUROBINDO PHARMA LTD203908AB (A-rated, therapeutically equivalent)October 8, 201510MG, 15MG, 20MG, 2MG, 30MG, 5MG
AMNEAL PHARMACEUTICALS204838AB (A-rated, therapeutically equivalent)June 17, 201610MG, 15MG, 20MG, 2MG, 30MG, 5MG
AJANTA PHARMA LTD206174AB (A-rated, therapeutically equivalent)September 12, 201610MG, 15MG, 20MG, 2MG, 30MG, 5MG
SCIEGEN PHARMACEUTICALS INC206383AB (A-rated, therapeutically equivalent)September 29, 201610MG, 15MG, 20MG, 2MG, 30MG, 5MG
MACLEODS PHARMACEUTICALS LTD204111AB (A-rated, therapeutically equivalent)October 7, 201610MG, 15MG, 20MG, 2MG, 30MG, 5MG
ACCORD HEALTHCARE INC206251AB (A-rated, therapeutically equivalent)December 7, 201610MG, 15MG, 20MG, 2MG, 30MG, 5MG
ORBION PHARMACEUTICALS PRIVATE LTD202683AB (A-rated, therapeutically equivalent)May 23, 201710MG, 15MG, 20MG, 2MG, 30MG, 5MG
PRINSTON PHARMACEUTICAL INC205363AB (A-rated, therapeutically equivalent)December 4, 201710MG, 15MG, 20MG, 2MG, 30MG, 5MG
ALKEM LABORATORIES LTD207105AB (A-rated, therapeutically equivalent)February 21, 201910MG, 15MG, 20MG, 2MG, 30MG, 5MG
UNICHEM LABORATORIES LTD203025AB (A-rated, therapeutically equivalent)December 1, 202110MG, 15MG, 20MG, 2MG, 30MG, 5MG
SUNSHINE LAKE PHARMA CO LTD213037AB (A-rated, therapeutically equivalent)October 2, 202310MG, 2MG, 5MG

Abilify Mycite Kit patents

Patents listed for Abilify Mycite Kit
PatentExpiresCoversUse codeNDA
11476952April 28, 2026Drug productNone207202
9125939July 28, 2026Method of useU-1749207202
7978064September 14, 2026Drug productNone207202
8759350March 2, 2027Method of useU-1529207202
9444503November 19, 2027Drug productU-2169207202
9119554December 16, 2028Drug productNone207202
9060708March 5, 2029Drug productNone207202
9258035March 5, 2029Drug productNone207202
8674825April 9, 2029Drug productU-2170207202
8956288July 6, 2029Drug productU-2167207202
10441194July 26, 2029Drug productNone207202
8945005August 19, 2029Drug productU-2167207202
9433371September 15, 2029Drug productNone207202
8718193December 5, 2029Drug productNone207202
9149577December 15, 2029Drug productNone207202
8847766March 29, 2030Drug productU-2167207202
8545402April 27, 2030Drug productNone207202
8114021June 21, 2030Drug productNone207202
11464423September 15, 2030Drug productNone207202
9941931November 4, 2030Drug productNone207202
8961412November 17, 2030Drug productNone207202
8258962November 25, 2030Drug productNone207202
8547248December 18, 2030Drug productU-2167207202
11229378July 11, 2031Drug productNone207202
9320455December 15, 2031Drug productNone207202
10517507June 13, 2032Drug productNone207202
9268909October 15, 2033Drug productU-2168207202

Questions

Is there a generic for Abilify Mycite Kit?

Yes. The generic name for Abilify Mycite Kit is aripiprazole. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Abilify Mycite Kit?

The active ingredient in Abilify Mycite Kit is aripiprazole, per the FDA Orange Book.

When does the Abilify Mycite Kit patent expire?

The last patent listed for Abilify Mycite Kit in the Orange Book expires October 15, 2033. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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