Dabigatran Etexilate Mesylate Patent Expiration

Dabigatran Etexilate Mesylate is used for preventing and treating blood clots. It was first introduced by Boehringer Ingelheim Pharmaceuticals Inc in its drug Pradaxa on Oct 19, 2010. 9 different companies have introduced drugs containing Dabigatran Etexilate Mesylate.


Dabigatran Etexilate Mesylate Patents

Given below is the list of patents protecting Dabigatran Etexilate Mesylate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Pradaxa US9034822

(Pediatric)

Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds Jul 20, 2031 Boehringer Ingelheim
Pradaxa US9034822 Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds Jan 20, 2031 Boehringer Ingelheim
Pradaxa US7866474

(Pediatric)

Film container Mar 02, 2028 Boehringer Ingelheim
Pradaxa US7866474 Film container Aug 31, 2027 Boehringer Ingelheim
Pradaxa US7932273

(Pediatric)

3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament Mar 07, 2026 Boehringer Ingelheim
Pradaxa US7932273 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament Sep 07, 2025 Boehringer Ingelheim
Pradaxa US9925174

(Pediatric)

Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof Dec 14, 2023

(Expired)

Boehringer Ingelheim
Pradaxa US9925174 Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof Jun 14, 2023

(Expired)

Boehringer Ingelheim
Pradaxa US6087380

(Pediatric)

Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions Jun 28, 2022

(Expired)

Boehringer Ingelheim
Pradaxa US6087380 Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions Dec 28, 2021

(Expired)

Boehringer Ingelheim
Pradaxa US6087380 Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions Feb 18, 2018

(Expired)

Boehringer Ingelheim



Dabigatran Etexilate Mesylate's Family Patents

Family Patents

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Dabigatran Etexilate Mesylate Generic API Manufacturers

Several generic applications have been filed for Dabigatran Etexilate Mesylate. The first generic version for Dabigatran Etexilate Mesylate was by Alkem Laboratories Ltd and was approved on Mar 11, 2020. And the latest generic version is by Mylan Pharmaceuticals Inc and was approved on Feb 3, 2025.

Given below is the list of companies who have filed for Dabigatran Etexilate Mesylate generic, along with the locations of their manufacturing plants worldwide.


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 75MG BASE

capsule Prescription ORAL AB Jun 14, 2024
EQ 150MG BASE

capsule Prescription ORAL AB Jun 14, 2024
EQ 110MG BASE

capsule Prescription ORAL AB Aug 12, 2024


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals Limited
Panelav Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd





2. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 150MG BASE

capsule Prescription ORAL AB Mar 11, 2020
EQ 75MG BASE

capsule Prescription ORAL AB Mar 11, 2020
EQ 110MG BASE

capsule Prescription ORAL AB Sep 11, 2024





3. APOTEX

Apotex Inc has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 150MG BASE

capsule Prescription ORAL AB Dec 15, 2023
EQ 75MG BASE

capsule Prescription ORAL AB Dec 15, 2023
EQ 110MG BASE

capsule Prescription ORAL AB Dec 15, 2023


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
Brantford Apotex Pharmachem Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





4. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 75MG BASE

capsule Prescription ORAL AB Dec 19, 2024
EQ 110MG BASE

capsule Prescription ORAL AB Dec 19, 2024
EQ 150MG BASE

capsule Prescription ORAL AB Dec 19, 2024


Manufacturing Plant Locations
New

Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.

Country City Firm Name
United States
Berlin Breckenridge Pharmaceutical, Inc
Boca Raton Breckenridge Pharmaceutical, Inc.





5. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 150MG BASE

capsule Prescription ORAL AB Jan 28, 2025
EQ 110MG BASE

capsule Prescription ORAL AB Jan 28, 2025
EQ 75MG BASE

capsule Prescription ORAL AB Jan 28, 2025





6. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 150MG BASE

capsule Prescription ORAL AB May 6, 2020
EQ 75MG BASE

capsule Prescription ORAL AB May 6, 2020
EQ 110MG BASE

capsule Prescription ORAL AB Aug 13, 2024





7. MSN

Msn Laboratories Private Ltd has filed for 3 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 150MG BASE

capsule Prescription ORAL AB May 22, 2024
EQ 75MG BASE

capsule Prescription ORAL AB May 22, 2024
EQ 110MG BASE

capsule Prescription ORAL AB Aug 12, 2024


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Sangareddy MSN Pharmachem Private Limited
Sangareddy MSN Laboratories Private Ltd.
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Limited, R&D Center
Kamareddy MSN Life Sciences Private Limited
Rangareddy District MSN Laboratories Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
United States
Piscataway MSN PHARMACEUTICALS INC





8. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Dabigatran Etexilate Mesylate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 75MG BASE

capsule Prescription ORAL AB Feb 3, 2025
EQ 150MG BASE

capsule Prescription ORAL AB Feb 3, 2025


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Rockford Mylan Institutional, Inc.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
India
Pithampur, District Dhar Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta