Is there a generic for Apixaban?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Apixaban, referencing the brand ELIQUIS SPRINKLE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Apixaban?

ELIQUIS SPRINKLE (NDA 220073, BRISTOL) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Apixaban?

The Orange Book lists 6 patents against Apixaban products, with the earliest listed expiry in 2026. 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 Apixaban have FDA marketing exclusivity?

Yes. The Orange Book records 8 marketing-exclusivity periods for Apixaban. 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 Apixaban are approved?

Apixaban is approved in the following dosage forms: for suspension, tablet, tablet, for suspension.

FDA Orange Book · active-ingredient family

Apixaban

Apixaban: 2 brands, 13 generics; first approved Dec 28, 2012; generic available.

Generic available8 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 13 ANDA applications approved.

Earliest patent expiry Nov 21, 2026Latest exclusivity ends Oct 17, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 21, 2026

in 3 mo

Brand (NDA) products

Originator applications

ELIQUIS SPRINKLERLDRS
BRISTOLNDA 2200732025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15MG FOR SUSPENSION ORAL Rx —
ELIQUISRLDRS
BRISTOL MYERS SQUIBBNDA 20215520253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
0.5MG TABLET, FOR SUSPENSION ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG	FOR SUSPENSION	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET, FOR SUSPENSION	ORAL	Rx	—

Generic (ANDA) products (13)

Abbreviated applications

APIXABAN
MACLEODS PHARMS LTDANDA 21006720252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
IMPAXANDA 20981020252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
TORRENTANDA 21015620242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
APOTEXANDA 21009120242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
HETERO LABS LTD VANDA 21006620232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
AUROBINDO PHARMA LTDANDA 21002620232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
ZYDUS PHARMSANDA 21018520232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
BRECKENRIDGEANDA 20984520212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
REGCON HOLDINGSANDA 20989820202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
APIXABAN
ACCORD HLTHCAREANDA 21018020202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
APIXABAN
BIONPHARMAANDA 21015220202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
MICRO LABSANDA 21001320192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
APIXABAN
MYLANANDA 21012820192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Apr 17, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 2 mo
NSNew strength exclusivity (3 years)
Apr 17, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 2 mo
NPPNew patient population exclusivity (3 years)
Apr 17, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 2 mo
NPPNew patient population exclusivity (3 years)
Apr 17, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 2 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
6967208	Nov 21, 2026	in 3 mo	SubstanceProductU-4180
6967208*PED	May 21, 2027	in 9 mo
9326945	Feb 24, 2031	in 4 yr 7 mo	Product
9326945*PED	Aug 24, 2031	in 5 yr 1 mo
11896586	Nov 22, 2040	in 14 yr 6 mo	ProductU-4180
11896586*PED	May 22, 2041	in 15 yr

Approval history

FDA approval span

First approval

Dec 28, 2012

13 yr 10 mo ago

Most recent approval

Apr 17, 2025

1 yr 4 mo ago

Approvals span 2012–2025 across 15 FDA applications.

Brand (NDA) 213%

Generic (ANDA) 1387%

Apixaban: 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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