FDA Orange Book

Generic for Farxiga

Farxiga contains dapagliflozin. 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 Farxiga is dapagliflozin. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Farxiga products in the Orange Book

Farxiga products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral10MGMarketed (Rx)AB15AB
tablet, oral5MGMarketed (Rx)AB15AB

NDA 202293, held by ASTRAZENECA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dapagliflozin

Approved generic versions of Farxiga
CompanyANDATE codeApprovedStrengths
AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD211523AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
AJANTA PHARMA LTD211482AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
ALEMBIC PHARMACEUTICALS LTD211560AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
ALKEM LABORATORIES LTD211545AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
AUROBINDO PHARMA LTD211468AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
BIOCON PHARMA LTD211470AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
CIPLA LTD211535AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
INVENTIA HEALTHCARE LTD211156AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
LUPIN LTD211531AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
MACLEODS PHARMACEUTICALS LTD211506AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
MICRO LABS LTD211467AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
MSN LABORATORIES PRIVATE LTD211478AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
SANDOZ INC211312AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
TEVA PHARMACEUTICALS USA INC211541AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG
ZYDUS PHARMACEUTICALS USA INC211582AB (A-rated, therapeutically equivalent)April 6, 202610MG, 5MG

Farxiga patents

Patents listed for Farxiga
PatentExpiresCoversUse codeNDA
6515117October 4, 2025Drug substance, Drug productU-493202293
6515117October 4, 2025Drug substance, Drug productU-2139202293
6515117*PEDApril 4, 2026Method of useNone202293
8906851August 18, 2026Method of useU-2139202293
8329648August 18, 2026Method of useU-2213202293
8329648August 18, 2026Method of useU-2139202293
8329648August 18, 2026Method of useU-2212202293
8329648*PEDFebruary 18, 2027Method of useNone202293
8906851*PEDFebruary 18, 2027Method of useNone202293
8501698June 20, 2027Drug productU-493202293
8501698*PEDDecember 20, 2027Method of useNone202293
8361972March 21, 2028Method of useU-2139202293
8361972March 21, 2028Method of useU-493202293
8221786March 21, 2028Drug productNone202293
8716251March 21, 2028Drug productNone202293
7851502August 19, 2028Drug productNone202293
8221786*PEDSeptember 21, 2028Method of useNone202293
8361972*PEDSeptember 21, 2028Method of useNone202293
8716251*PEDSeptember 21, 2028Method of useNone202293
7851502*PEDFebruary 19, 2029Method of useNone202293
7919598December 16, 2029Drug substanceNone202293
8721615January 18, 2030Drug productNone202293
8685934May 26, 2030Method of useU-1522202293
7919598*PEDJune 16, 2030Method of useNone202293
8721615*PEDJuly 18, 2030Method of useNone202293
8685934*PEDNovember 26, 2030Method of useNone202293
12472194July 18, 2039Method of useU-4346202293
11826376July 18, 2039Method of useU-3766202293
12472194*PEDJanuary 18, 2040Method of useNone202293
11826376*PEDJanuary 18, 2040Method of useNone202293
10973836March 9, 2040Method of useU-3127202293
11903955March 9, 2040Method of useU-3825202293
11903955*PEDSeptember 9, 2040Method of useNone202293
10973836*PEDSeptember 9, 2040Method of useNone202293
12213988April 1, 2041Method of useU-4140202293
12409186April 1, 2041Method of useU-4140202293
12409186*PEDOctober 1, 2041Method of useNone202293
12213988*PEDOctober 1, 2041Method of useNone202293

Farxiga exclusivity

Exclusivity listed for Farxiga
CodeMeaningExpiresNDA
M-298MiscellaneousMay 8, 2026202293
PEDPediatric exclusivityNovember 8, 2026202293
NPPNew patient populationJune 12, 2027202293
PEDPediatric exclusivityDecember 12, 2027202293

Farxiga NDC codes

Questions

Is there a generic for Farxiga?

Yes. The generic name for Farxiga is dapagliflozin. 15 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 Farxiga?

The active ingredient in Farxiga is dapagliflozin, per the FDA Orange Book.

When does the Farxiga patent expire?

The last patent listed for Farxiga in the Orange Book expires October 1, 2041. 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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