FDA Orange Book

Generic for Eliquis

Eliquis contains apixaban. 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 Eliquis is apixaban. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Eliquis products the Orange Book lists.

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Eliquis products in the Orange Book

Eliquis products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, for suspension, oral0.5MGMarketed (Rx)None0None
tablet, oral2.5MGMarketed (Rx)AB2AB
tablet, oral5MGMarketed (Rx)AB2AB

NDA 202155, held by BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic apixaban

Approved generic versions of Eliquis
CompanyANDATE codeApprovedStrengths
ACCORD HEALTHCARE INC210180AB (A-rated, therapeutically equivalent)July 28, 20202.5MG, 5MG
REGCON HOLDINGS LLC209898AB (A-rated, therapeutically equivalent)September 11, 20202.5MG, 5MG

Eliquis patents

Patents listed for Eliquis
PatentExpiresCoversUse codeNDA
6967208November 21, 2026Drug substance, Drug productU-4179202155
6967208November 21, 2026Drug substance, Drug productU-1501202155
6967208November 21, 2026Drug substance, Drug productU-1200202155
6967208November 21, 2026Drug substance, Drug productU-1302202155
6967208November 21, 2026Drug substance, Drug productU-1729202155
6967208November 21, 2026Drug substance, Drug productU-1730202155
6967208November 21, 2026Drug substance, Drug productU-1301202155
6967208November 21, 2026Drug substance, Drug productU-1167202155
6967208November 21, 2026Drug substance, Drug productU-4178202155
6967208November 21, 2026Drug substance, Drug productU-1323202155
6967208November 21, 2026Drug substance, Drug productU-1502202155
6967208*PEDMay 21, 2027Method of useNone202155
9326945February 24, 2031Drug productNone202155
9326945*PEDAugust 24, 2031Method of useNone202155

Eliquis exclusivity

Exclusivity listed for Eliquis
CodeMeaningExpiresNDA
NSNew strengthApril 17, 2028202155
NPPNew patient populationApril 17, 2028202155
PEDPediatric exclusivityOctober 17, 2028202155

Eliquis NDC codes

Questions

Is there a generic for Eliquis?

Yes. The generic name for Eliquis is apixaban. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Eliquis products the Orange Book lists.

What is the generic name for Eliquis?

The active ingredient in Eliquis is apixaban, per the FDA Orange Book.

When does the Eliquis patent expire?

The last patent listed for Eliquis in the Orange Book expires August 24, 2031. 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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