dabigatran etexilate mesylate · Boehringer Ingelheim · NDA 022512, 214358
Pradaxa
6 of 9 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 9034822 (pediatric extension).
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9034822 | use U-1759 | 20 Jul 2031 |
| US 9034822 listing row | use U-1759 | 20 Jan 2031 |
| US 9034822 listing row | pediatric extension · sets the listed date | 20 Jul 2031 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022512 · 001 · RLD | capsule, oral | EQ 75MG BASE | 20 Jul 2031 |
| 022512 · 002 · RLD | capsule, oral | EQ 150MG BASE | 20 Jul 2031 |
| 022512 · 003 · RLD | capsule, oral | EQ 110MG BASE | 20 Jul 2031 |
| 214358 · 001 · RLD | pellets, oral | EQ 20MG BASE/PACKET | open |
| 214358 · 002 · RLD | pellets, oral | EQ 30MG BASE/PACKET | open |
| 214358 · 003 · RLD | pellets, oral | EQ 40MG BASE/PACKET | open |
| 214358 · 004 · RLD | pellets, oral | EQ 50MG BASE/PACKET | open |
| 214358 · 005 · RLD | pellets, oral | EQ 110MG BASE/PACKET | open |
| 214358 · 006 · RLD | pellets, oral | EQ 150MG BASE/PACKET | open |
Expired or delisted (2)
- US 7932273 · — · 7 Mar 2026
- US 7932273 · substance, product · 7 Sep 2025