FDA Orange Book · active-ingredient family
Dabigatran etexilate mesylate
Dabigatran etexilate mesylate is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRADAXA · NDA 214358
2
Brand (NDA)
9
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, pellets
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRADAXARLD×6 | BOEHRINGER INGELHEIM | NDA 214358 | — | Jun 21, 2021 | |
| PRADAXARLD×3 | BOEHRINGER INGELHEIM | NDA 022512 | AB | Oct 19, 2010 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE×3 | AUROBINDO PHARMA | ANDA 208039 | AB | May 14, 2025 | |
| DABIGATRAN ETEXILATE MESYLATE×2 | MYLAN | ANDA 208067 | AB | Feb 03, 2025 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | DR REDDYS | ANDA 208048 | AB | Jan 28, 2025 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | BRECKENRIDGE | ANDA 207922 | — | Dec 19, 2024 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | ALEMBIC | ANDA 215233 | AB | Jun 14, 2024 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | MSN | ANDA 213879 | AB | May 22, 2024 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | APOTEX | ANDA 208070 | AB | Dec 15, 2023 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | HETERO LABS LTD III | ANDA 207961 | AB | May 06, 2020 | |
| DABIGATRAN ETEXILATE MESYLATE×3 | ALKEM LABS LTD | ANDA 208040 | AB | Mar 11, 2020 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7932273 | Sep 07, 2025 | 10 mo ago | SubstanceProduct |
| 7932273*PED | Mar 07, 2026 | 3 mo ago | |
| 9034822 | Jan 20, 2031 | in 4 yr 8 mo | U-1759 |
| 9034822*PED | Jul 20, 2031 | in 5 yr 2 mo |
Dabigatran etexilate mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
