Is there a generic for Dapagliflozin?

Yes. The FDA Orange Book lists 15 approved generic (ANDA) applications for Dapagliflozin, referencing the brand FARXIGA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dapagliflozin?

FARXIGA (NDA 202293, ASTRAZENECA AB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Dapagliflozin?

The Orange Book lists 34 patents against Dapagliflozin products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Dapagliflozin have FDA marketing exclusivity?

Yes. The Orange Book records 26 marketing-exclusivity periods for Dapagliflozin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Dapagliflozin are approved?

Dapagliflozin is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Dapagliflozin

Dapagliflozin is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FARXIGA · NDA 202293

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
FARXIGARLD×2	ASTRAZENECA AB	NDA 202293	AB	Jan 08, 2014

Generic (ANDA) products (15)

Product	Applicant	Application	TE	Approved
DAPAGLIFLOZIN×2	AIZANT	ANDA 211523	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	AJANTA PHARMA LTD	ANDA 211482	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	ALEMBIC	ANDA 211560	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	ALKEM LABS LTD	ANDA 211545	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	AUROBINDO PHARMA	ANDA 211468	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	BIOCON PHARMA	ANDA 211470	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	CIPLA	ANDA 211535	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	INVENTIA	ANDA 211156	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	LUPIN	ANDA 211531	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	MACLEODS PHARMS LTD	ANDA 211506	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	MICRO LABS	ANDA 211467	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	MSN	ANDA 211478	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	SANDOZ	ANDA 211312	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	TEVA PHARMS USA	ANDA 211541	AB	Apr 06, 2026
DAPAGLIFLOZIN×2	ZYDUS PHARMS	ANDA 211582	AB	Apr 06, 2026

Marketing exclusivity (26)

PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
M-298New use / labeling-change exclusivity (3 years)
May 08, 2026
1 mo ago
NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2026
in 5 mo
PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
M-298New use / labeling-change exclusivity (3 years)
May 08, 2026
1 mo ago
NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2026
in 5 mo
PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo

Listed patents (34)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6515117	Oct 04, 2025	9 mo ago	SubstanceProductU-493
6515117*PED	Apr 04, 2026	3 mo ago
8906851	Aug 18, 2026	in 2 mo	U-2139
8329648	Aug 18, 2026	in 2 mo	U-2213
8329648*PED	Feb 18, 2027	in 8 mo
8906851*PED	Feb 18, 2027	in 8 mo
8501698	Jun 20, 2027	in 1 yr	ProductU-493
8501698*PED	Dec 20, 2027	in 1 yr 6 mo
8361972	Mar 21, 2028	in 1 yr 9 mo	U-2139
8221786	Mar 21, 2028	in 1 yr 9 mo	Product
8716251	Mar 21, 2028	in 1 yr 9 mo	Product
7851502	Aug 19, 2028	in 2 yr 2 mo	Product
8221786*PED	Sep 21, 2028	in 2 yr 4 mo
8361972*PED	Sep 21, 2028	in 2 yr 4 mo
8716251*PED	Sep 21, 2028	in 2 yr 4 mo
7851502*PED	Feb 19, 2029	in 2 yr 9 mo
7919598	Dec 16, 2029	in 3 yr 7 mo	Substance
8721615	Jan 18, 2030	in 3 yr 8 mo	ProductDelisted
8685934	May 26, 2030	in 4 yr	U-1522
7919598*PED	Jun 16, 2030	in 4 yr 1 mo
8721615*PED	Jul 18, 2030	in 4 yr 2 mo
8685934*PED	Nov 26, 2030	in 4 yr 6 mo
12472194	Jul 18, 2039	in 13 yr 3 mo	U-4346
11826376	Jul 18, 2039	in 13 yr 3 mo	U-3766
12472194*PED	Jan 18, 2040	in 13 yr 9 mo
11826376*PED	Jan 18, 2040	in 13 yr 9 mo
10973836	Mar 09, 2040	in 13 yr 11 mo	U-3127
11903955	Mar 09, 2040	in 13 yr 11 mo	U-3825
11903955*PED	Sep 09, 2040	in 14 yr 5 mo
10973836*PED	Sep 09, 2040	in 14 yr 5 mo
12213988	Apr 01, 2041	in 15 yr	U-4140
12409186	Apr 01, 2041	in 15 yr	U-4140
12409186*PED	Oct 01, 2041	in 15 yr 6 mo
12213988*PED	Oct 01, 2041	in 15 yr 6 mo

Dapagliflozin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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