FDA Orange Book

Generic for Exelon

Exelon contains rivastigmine. 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 Exelon is rivastigmine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Exelon products the Orange Book lists.

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Exelon products in the Orange Book

Exelon products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 1.5MG BASEDiscontinuedNone8AB
capsule, oralEQ 3MG BASEDiscontinuedNone8AB
capsule, oralEQ 4.5MG BASEDiscontinuedNone8AB
capsule, oralEQ 6MG BASEDiscontinuedNone8AB
film, extended release, transdermal13.3MG/24HRMarketed (Rx)AB5AB
film, extended release, transdermal4.6MG/24HRMarketed (Rx)AB5AB
film, extended release, transdermal9.5MG/24HRMarketed (Rx)AB5AB
solution, oralEQ 2MG BASE/MLDiscontinuedNone0None

NDA 020823, 022083, 021025, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic rivastigmine

Approved generic versions of Exelon
CompanyANDATE codeApprovedStrengths
DR REDDYS LABORATORIES INC077130AB (A-rated, therapeutically equivalent)October 31, 2007EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
WATSON LABORATORIES INC077129AB (A-rated, therapeutically equivalent)January 8, 2008EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
ALEMBIC PHARMACEUTICALS LTD091689AB (A-rated, therapeutically equivalent)June 12, 2012EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
MACLEODS PHARMACEUTICALS LTD203148AB (A-rated, therapeutically equivalent)August 22, 2014EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
ORBION PHARMACEUTICALS PRIVATE LTD090879AB (A-rated, therapeutically equivalent)June 10, 2015EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
AUROBINDO PHARMA LTD204572AB (A-rated, therapeutically equivalent)March 25, 2016EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
CADILA PHARMACEUTICALS LTD203844AB (A-rated, therapeutically equivalent)February 13, 2017EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
CHARTWELL RX SCIENCES LLC207797AB (A-rated, therapeutically equivalent)September 28, 2017EQ 1.5MG BASE, EQ 3MG BASE, EQ 4.5MG BASE, EQ 6MG BASE
MYLAN TECHNOLOGIES INC205622AB (A-rated, therapeutically equivalent)June 20, 201813.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR
AMNEAL PHARMACEUTICALS OF NEW YORK LLC207308AB (A-rated, therapeutically equivalent)January 8, 201913.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR
ZYDUS PHARMACEUTICALS USA INC206318AB (A-rated, therapeutically equivalent)March 4, 201913.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR
BRECKENRIDGE PHARMACEUTICAL INC209063AB (A-rated, therapeutically equivalent)November 26, 201913.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR
YICHANG HUMANWELL PHARMACEUTICAL CO LTD215445AB (A-rated, therapeutically equivalent)September 23, 202513.3MG/24HR, 4.6MG/24HR, 9.5MG/24HR

Exelon NDC codes

Questions

Is there a generic for Exelon?

Yes. The generic name for Exelon is rivastigmine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Exelon products the Orange Book lists.

What is the generic name for Exelon?

The active ingredient in Exelon is rivastigmine, per the FDA Orange Book.

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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