FDA Orange Book
Generic for Pradaxa
Pradaxa contains dabigatran etexilate. 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 Pradaxa is dabigatran etexilate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 9 Pradaxa products the Orange Book lists.
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Pradaxa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 110MG BASE | Marketed (Rx) | AB | 7 | AB |
| capsule, oral | EQ 150MG BASE | Marketed (Rx) | AB | 8 | AB |
| capsule, oral | EQ 75MG BASE | Marketed (Rx) | AB | 8 | AB |
| pellets, oral | EQ 110MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 150MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 20MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 30MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 40MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | EQ 50MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
NDA 022512, 214358, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dabigatran etexilate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 208070 | AB (A-rated, therapeutically equivalent) | December 15, 2023 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 215233 | AB (A-rated, therapeutically equivalent) | August 12, 2024 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
| MSN LABORATORIES PRIVATE LTD | 213879 | AB (A-rated, therapeutically equivalent) | August 12, 2024 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
| HETERO LABS LTD UNIT III | 207961 | AB (A-rated, therapeutically equivalent) | August 13, 2024 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
| ALKEM LABORATORIES LTD | 208040 | AB (A-rated, therapeutically equivalent) | September 11, 2024 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
| DR REDDYS LABORATORIES LTD | 208048 | AB (A-rated, therapeutically equivalent) | January 28, 2025 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
| MYLAN PHARMACEUTICALS INC | 208067 | AB (A-rated, therapeutically equivalent) | February 3, 2025 | EQ 150MG BASE, EQ 75MG BASE |
| AUROBINDO PHARMA LTD | 208039 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | EQ 110MG BASE, EQ 150MG BASE, EQ 75MG BASE |
Pradaxa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7932273 | September 7, 2025 | Drug substance, Drug product | None | 022512 |
| 7932273*PED | March 7, 2026 | Method of use | None | 022512 |
| 9034822 | January 20, 2031 | Method of use | U-1759 | 022512 |
| 9034822*PED | July 20, 2031 | Method of use | None | 022512 |
Pradaxa NDC codes
Questions
Is there a generic for Pradaxa?
Yes. The generic name for Pradaxa is dabigatran etexilate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 9 Pradaxa products the Orange Book lists.
What is the generic name for Pradaxa?
The active ingredient in Pradaxa is dabigatran etexilate, per the FDA Orange Book.
When does the Pradaxa patent expire?
The last patent listed for Pradaxa in the Orange Book expires July 20, 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 Pradaxa and Dabigatran Etexilate
- What is Pradaxa used for?FDA label uses
- Is Pradaxa a controlled substance?Federal schedule
- What is Dabigatran Etexilate used for?FDA label uses
- Is Dabigatran Etexilate a controlled substance?Federal schedule
- Direct Thrombin Inhibitors listFDA drug class
- NDC 0597-0108Pradaxa NDC record
- NDC 0597-0355Pradaxa NDC record
- NDC 0597-0360Pradaxa NDC record