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: 1 brand, 15 generics; first approved Jan 08, 2014; generic available.

Generic available26 exclusivity periods

Generic status & protection

Generic available: 15 ANDA applications approved.

Earliest patent expiry Oct 04, 2025Latest exclusivity ends Dec 12, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 04, 2025

10 mo ago

Brand (NDA) products

Originator applications

FARXIGARLD
ASTRAZENECA ABNDA 20229320142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (15)

Abbreviated applications

DAPAGLIFLOZIN
AIZANTANDA 21152320262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
AJANTA PHARMA LTDANDA 21148220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
ALEMBICANDA 21156020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
ALKEM LABS LTDANDA 21154520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
AUROBINDO PHARMAANDA 21146820262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
BIOCON PHARMAANDA 21147020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
CIPLAANDA 21153520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
INVENTIAANDA 21115620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
LUPINANDA 21153120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
MACLEODS PHARMS LTDANDA 21150620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
MICRO LABSANDA 21146720262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
MSNANDA 21147820262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
SANDOZANDA 21131220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
TEVA PHARMS USAANDA 21154120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DAPAGLIFLOZIN
ZYDUS PHARMSANDA 21158220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 2 mo
M-298New use / labeling-change exclusivity (3 years)
May 08, 2026
3 mo ago
NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2026
in 3 mo
PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 4 mo
M-298New use / labeling-change exclusivity (3 years)
May 08, 2026
3 mo ago
NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2026
in 3 mo
PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 4 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6515117	Oct 04, 2025	10 mo ago	SubstanceProductU-493
6515117*PED	Apr 04, 2026	4 mo ago
8906851	Aug 18, 2026	in 6 d	U-2139
8329648	Aug 18, 2026	in 6 d	U-2213
8329648*PED	Feb 18, 2027	in 6 mo
8906851*PED	Feb 18, 2027	in 6 mo
8501698	Jun 20, 2027	in 10 mo	ProductU-493
8501698*PED	Dec 20, 2027	in 1 yr 5 mo
8361972	Mar 21, 2028	in 1 yr 8 mo	U-2139
8221786	Mar 21, 2028	in 1 yr 8 mo	Product
8716251	Mar 21, 2028	in 1 yr 8 mo	Product
7851502	Aug 19, 2028	in 2 yr 1 mo	Product
8221786*PED	Sep 21, 2028	in 2 yr 2 mo
8361972*PED	Sep 21, 2028	in 2 yr 2 mo
8716251*PED	Sep 21, 2028	in 2 yr 2 mo
7851502*PED	Feb 19, 2029	in 2 yr 7 mo
7919598	Dec 16, 2029	in 3 yr 5 mo	Substance
8721615	Jan 18, 2030	in 3 yr 6 mo	ProductDelisted
8685934	May 26, 2030	in 3 yr 10 mo	U-1522
7919598*PED	Jun 16, 2030	in 3 yr 11 mo
8721615*PED	Jul 18, 2030	in 4 yr
8685934*PED	Nov 26, 2030	in 4 yr 4 mo
12472194	Jul 18, 2039	in 13 yr 1 mo	U-4346
11826376	Jul 18, 2039	in 13 yr 1 mo	U-3766
12472194*PED	Jan 18, 2040	in 13 yr 8 mo
11826376*PED	Jan 18, 2040	in 13 yr 8 mo
10973836	Mar 09, 2040	in 13 yr 9 mo	U-3127
11903955	Mar 09, 2040	in 13 yr 9 mo	U-3825
11903955*PED	Sep 09, 2040	in 14 yr 3 mo
10973836*PED	Sep 09, 2040	in 14 yr 3 mo
12213988	Apr 01, 2041	in 14 yr 10 mo	U-4140
12409186	Apr 01, 2041	in 14 yr 10 mo	U-4140
12409186*PED	Oct 01, 2041	in 15 yr 4 mo
12213988*PED	Oct 01, 2041	in 15 yr 4 mo

Approval history

FDA approval span

First approval

Jan 08, 2014

12 yr 9 mo ago

Most recent approval

Apr 06, 2026

4 mo ago

Approvals span 2014–2026 across 16 FDA applications.

Brand (NDA) 16%

Generic (ANDA) 1594%

Dapagliflozin: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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