FDA Orange Book · active-ingredient family
Dabigatran etexilate mesylate
Dabigatran etexilate mesylate: 2 brands, 9 generics; first approved Oct 19, 2010; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
4
Next patent expiry
Sep 07, 2025
1 yr ago
Brand (NDA) products
Originator applications
- PRADAXARLDBOEHRINGER INGELHEIMNDA 21435820216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/PACKET PELLETS ORAL Rx — EQ 30MG BASE/PACKET PELLETS ORAL Rx — EQ 40MG BASE/PACKET PELLETS ORAL Rx — EQ 50MG BASE/PACKET PELLETS ORAL Rx — EQ 110MG BASE/PACKET PELLETS ORAL Rx — EQ 150MG BASE/PACKET PELLETS ORAL Rx — - PRADAXARLDBOEHRINGER INGELHEIMNDA 02251220103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- DABIGATRAN ETEXILATE MESYLATEAUROBINDO PHARMAANDA 20803920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEMYLANANDA 20806720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEDR REDDYSANDA 20804820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEBRECKENRIDGEANDA 20792220243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Discontinued — EQ 150MG BASE CAPSULE ORAL Discontinued — EQ 110MG BASE CAPSULE ORAL Discontinued — - DABIGATRAN ETEXILATE MESYLATEALEMBICANDA 21523320243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEMSNANDA 21387920243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEAPOTEXANDA 20807020233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEHETERO LABS LTD IIIANDA 20796120203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB - DABIGATRAN ETEXILATE MESYLATEALKEM LABS LTDANDA 20804020203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 110MG BASE CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7932273 | 1 yr ago | SubstanceProduct | |
| 7932273*PED | 6 mo ago | ||
| 9034822 | in 4 yr 6 mo | U-1759 | |
| 9034822*PED | in 5 yr |
Approval history
FDA approval span
First approval
16 yr 1 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 2010–2025 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Dabigatran etexilate mesylate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
