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
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 0.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 2 | AB |
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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 210180 | AB (A-rated, therapeutically equivalent) | July 28, 2020 | 2.5MG, 5MG |
| REGCON HOLDINGS LLC | 209898 | AB (A-rated, therapeutically equivalent) | September 11, 2020 | 2.5MG, 5MG |
Eliquis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-4179 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1501 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1200 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1302 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1729 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1730 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1301 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1167 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-4178 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1323 | 202155 |
| 6967208 | November 21, 2026 | Drug substance, Drug product | U-1502 | 202155 |
| 6967208*PED | May 21, 2027 | Method of use | None | 202155 |
| 9326945 | February 24, 2031 | Drug product | None | 202155 |
| 9326945*PED | August 24, 2031 | Method of use | None | 202155 |
Eliquis exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | April 17, 2028 | 202155 |
| NPP | New patient population | April 17, 2028 | 202155 |
| PED | Pediatric exclusivity | October 17, 2028 | 202155 |
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.
More on Eliquis and Apixaban
- What is Eliquis used for?FDA label uses
- Is Eliquis a controlled substance?Federal schedule
- Generic for Eliquis SprinkleFDA Orange Book
- Factor Xa Inhibitors listFDA drug class
- Eliquis Medicare Part D coverageBy plan and state
- NDC 0003-0893Eliquis NDC record
- NDC 0003-0894Eliquis NDC record
- NDC 0003-1028Eliquis NDC record