Pradaxa is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2013 to 2021. Out of these, 6 drug patents are active and 4 have expired. Pradaxa's patents have been open to challenges since 22 December, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 20, 2031. Details of Pradaxa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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, 2025
(8 months from now) | Active |
| US6087380 | Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions |
Dec, 2021
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9034822 (Pediatric) | Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds |
Jul, 2031
(6 years from now) | Active |
| US9034822 | Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds |
Jan, 2031
(6 years from now) | Active |
|
US7866474 (Pediatric) | Film container |
Mar, 2028
(3 years from now) | Active |
| US7866474 | Film container |
Aug, 2027
(2 years from now) | Active |
|
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, 2026
(1 year, 2 months from now) | Active |
|
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, 2023
(1 year, 5 days ago) |
Expired
|
| 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, 2023
(1 year, 6 months ago) |
Expired
|
|
US6087380 (Pediatric) | Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions |
Jun, 2022
(2 years ago) |
Expired
|
| US6087380 | Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions |
Feb, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Pradaxa's patents.
Latest Legal Activities on Pradaxa's Patents
Given below is the list of recent legal activities going on the following patents of Pradaxa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Nov, 2022 | US9034822 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Oct, 2022 | US7932273 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Jul, 2022 | US7866474 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Sep, 2021 | US9925174 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Nov, 2018 | US9034822 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Oct, 2018 | US7932273 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jul, 2018 | US7866474 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Mar, 2018 | US9925174 |
| Recordation of Patent Grant Mailed Critical | 27 Mar, 2018 | US9925174 |
| Email Notification Critical | 08 Mar, 2018 | US9925174 |
FDA has granted several exclusivities to Pradaxa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pradaxa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Pradaxa.
Exclusivity Information
Pradaxa holds 8 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Pradaxa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 19, 2015 |
| New Indication(I-682) | Apr 04, 2017 |
| New Indication(I-683) | Apr 04, 2017 |
| M(M-168) | Nov 20, 2018 |
| New Strength(NS) | Nov 20, 2018 |
| New Indication(I-862) | Jun 21, 2024 |
| New Product(NP) | Jun 21, 2024 |
| Pediatric Exclusivity(PED) | Dec 21, 2024 |
Several oppositions have been filed on Pradaxa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Pradaxa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Pradaxa patents.
Pradaxa's Oppositions Filed in EPO
Pradaxa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 29, 2010, by Apotex Inc.. This opposition was filed on patent number EP04764411A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP03743368A | Apr, 2013 | Sanovel IIaç San. ve Tic. A.S. | Patent maintained as amended |
| EP03743368A | Mar, 2013 | Stötter, Gerd | Patent maintained as amended |
| EP07115663A | Oct, 2012 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP07115663A | Oct, 2012 | Stötter, Gerd | Revoked |
| EP09153155A | Jul, 2012 | PONS PATENTES Y MARCAS INTERNACIONAL, S.L. | Revoked |
| EP09153155A | Jul, 2012 | Sanovel Ilac Sanayii ve Ticaret A.S. | Revoked |
| EP09153155A | Jul, 2012 | Stötter, Gerd | Revoked |
| EP04764411A | Jan, 2010 | APOTEX INC. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Pradaxa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Pradaxa's family patents as well as insights into ongoing legal events on those patents.
Pradaxa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pradaxa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 20, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pradaxa Generic API suppliers:
Dabigatran Etexilate Mesylate is the generic name for the brand Pradaxa. 5 different companies have already filed for the generic of Pradaxa, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pradaxa's generic
How can I launch a generic of Pradaxa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pradaxa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pradaxa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Pradaxa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| eq. to 75 mg base and 150 mg base | 20 Oct, 2014 | 17 | 06 May, 2020 | 31 Aug, 2027 | Eligible |
| eq. to 110 mg base | 15 Dec, 2015 | 2 | 20 Jan, 2031 |
About Pradaxa
Pradaxa is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for preventing and treating blood clots. Pradaxa uses Dabigatran Etexilate Mesylate as an active ingredient. Pradaxa was launched by Boehringer Ingelheim in 2010.
Approval Date:
Pradaxa was approved by FDA for market use on 19 October, 2010.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Pradaxa is 19 October, 2010, its NCE-1 date is estimated to be 22 December, 2023.
Active Ingredient:
Pradaxa uses Dabigatran Etexilate Mesylate as the active ingredient. Check out other Drugs and Companies using Dabigatran Etexilate Mesylate ingredient
Treatment:
Pradaxa is used for preventing and treating blood clots.
Dosage:
Pradaxa is available in the following dosage forms - capsule form for oral use, pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 75MG BASE | CAPSULE | Prescription | ORAL |
| EQ 110MG BASE | CAPSULE | Prescription | ORAL |
| EQ 150MG BASE | CAPSULE | Prescription | ORAL |
| EQ 20MG BASE/PACKET | PELLETS | Prescription | ORAL |
| EQ 150MG BASE/PACKET | PELLETS | Prescription | ORAL |
| EQ 110MG BASE/PACKET | PELLETS | Prescription | ORAL |
| EQ 50MG BASE/PACKET | PELLETS | Prescription | ORAL |
| EQ 40MG BASE/PACKET | PELLETS | Prescription | ORAL |
| EQ 30MG BASE/PACKET | PELLETS | Prescription | ORAL |