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Last Updated: September 25, 2022

PRADAXA Drug Patent Profile


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When do Pradaxa patents expire, and when can generic versions of Pradaxa launch?

Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and sixty-seven patent family members in fifty-two countries.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.

Drug patent expirations by year for PRADAXA
Drug Prices for PRADAXA

See drug prices for PRADAXA

Drug Sales Revenue Trends for PRADAXA

See drug sales revenues for PRADAXA

Recent Clinical Trials for PRADAXA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Laval UniversityPhase 2
BayerPhase 1
Institute of Cardiology, Warsaw, PolandPhase 4

See all PRADAXA clinical trials

Pharmacology for PRADAXA
Paragraph IV (Patent) Challenges for PRADAXA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRADAXA Capsules dabigatran etexilate mesylate eq. to 110 mg base 022512 2 2015-12-15
PRADAXA Capsules dabigatran etexilate mesylate eq. to 75 mg base and 150 mg base 022512 17 2014-10-20

US Patents and Regulatory Information for PRADAXA

PRADAXA is protected by five US patents and three FDA Regulatory Exclusivities.

Patents protecting PRADAXA

Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Film container
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-me- thyl-1 H-benzimidazol acid ethyl ester and the salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting PRADAXA

TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-004 Jun 21, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-003 Jun 21, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-006 Jun 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-005 Jun 21, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-006 Jun 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-002 Jun 21, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PRADAXA

When does loss-of-exclusivity occur for PRADAXA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5520
Estimated Expiration: See Plans and Pricing

Patent: 3225
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04274139
Estimated Expiration: See Plans and Pricing

Patent: 10201457
Estimated Expiration: See Plans and Pricing

Austria

Patent: 0145
Estimated Expiration: See Plans and Pricing

Patent: 9420
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0413849
Estimated Expiration: See Plans and Pricing

Canada

Patent: 37054
Estimated Expiration: See Plans and Pricing

Patent: 49579
Estimated Expiration: See Plans and Pricing

China

Patent: 45917
Estimated Expiration: See Plans and Pricing

Patent: 2167695
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60265
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0090311
Estimated Expiration: See Plans and Pricing

Patent: 0120028
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 09299
Estimated Expiration: See Plans and Pricing

Patent: 12222
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 60482
Estimated Expiration: See Plans and Pricing

Patent: 60569
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066399
Estimated Expiration: See Plans and Pricing

Patent: 11006399
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9736
Estimated Expiration: See Plans and Pricing

Patent: 0600381
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 60482
Estimated Expiration: See Plans and Pricing

Patent: 60569
Estimated Expiration: See Plans and Pricing

Germany

Patent: 339862
Estimated Expiration: See Plans and Pricing

Patent: 2004009431
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 96682
Estimated Expiration: See Plans and Pricing

Patent: 57760
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3885
Estimated Expiration: See Plans and Pricing

Japan

Patent: 48842
Estimated Expiration: See Plans and Pricing

Patent: 66332
Estimated Expiration: See Plans and Pricing

Patent: 07504106
Estimated Expiration: See Plans and Pricing

Patent: 11178803
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 5632
Estimated Expiration: See Plans and Pricing

Patent: 5696
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06001959
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 340
Estimated Expiration: See Plans and Pricing

Patent: 0608
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5984
Estimated Expiration: See Plans and Pricing

Patent: 8586
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4115
Estimated Expiration: See Plans and Pricing

Patent: 061420
Estimated Expiration: See Plans and Pricing

Patent: 130778
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050348
Estimated Expiration: See Plans and Pricing

Poland

Patent: 60482
Estimated Expiration: See Plans and Pricing

Patent: 60569
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 60482
Estimated Expiration: See Plans and Pricing

Patent: 60569
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 370
Estimated Expiration: See Plans and Pricing

Patent: 060136
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 5734
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 60482
Estimated Expiration: See Plans and Pricing

Patent: 60569
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0600518
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1331039
Estimated Expiration: See Plans and Pricing

Patent: 070031830
Estimated Expiration: See Plans and Pricing

Patent: 130041381
Estimated Expiration: See Plans and Pricing

Patent: 130041382
Estimated Expiration: See Plans and Pricing

Spain

Patent: 26654
Estimated Expiration: See Plans and Pricing

Patent: 75896
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 75674
Estimated Expiration: See Plans and Pricing

Patent: 18553
Estimated Expiration: See Plans and Pricing

Patent: 0512206
Estimated Expiration: See Plans and Pricing

Patent: 1202217
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 686
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 493
Estimated Expiration: See Plans and Pricing

Patent: 342
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PRADAXA around the world.

Country Patent Number Title Estimated Expiration
Denmark 2060569 See Plans and Pricing
Slovakia 112199 DISUBSTITUTED BICYCLIC HETEROCYCLES, THEIR PRODUCTION AND USE AS MEDICAMENTS See Plans and Pricing
Germany 102004062864 Folienbehälter See Plans and Pricing
China 102711813 Anticoagulant antidotes See Plans and Pricing
Ukraine 95601 МЕТАНСУЛЬФОНАТ ЭТИЛОВОГО ЭФИРА 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНИЛАМИНОИМИНОМЕТИЛ)ФЕНИЛАМИНО]МЕТИЛ}-1МЕТИЛ-1Н- БЕНЗИМИДАЗОЛ-5-КАРБОНИЛ)ПИРИДИН-2-ИЛАМИНО]ПРОПИОНОВОЙ КИСЛОТЫ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕГО СОДЕРЖИТ;МЕТАНСУЛЬФОНАТ ЕТИЛОВОГО ЕФІРУ 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНІЛАМІНОІМІНОМЕТИЛ)ФЕНІЛАМІНО]МЕТИЛ}-1МЕТИЛ-1Н-БЕНЗИМІДАЗОЛ-5-КАРБОНІЛ)ПІРИДИН-2-ІЛАМІНО]ПРОПІОНОВОЇ КИСЛОТИ ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЙОГО МІСТИТЬ (3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER-METHANESULPHONATE AND PHARMACEUTICAL COMPOSITION COMPRISING THEREOF) See Plans and Pricing
Australia 2010201457 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridine-2-yl-amino]-propionic acid ethyl ester methane sulphonate and use thereof as a medicament See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRADAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1485094 00122 Estonia See Plans and Pricing
1485094 54/2012 Austria See Plans and Pricing PRODUCT NAME: DABIGATRANETEXILAT UND SEINE SALZE, INSBESONDERE DABIGATRANETEXILATMESILAT; REGISTRATION NO/DATE: EU/1/08/442/001 - EU1/08/442/008 20080318
0966454 SPC/GB08/037 United Kingdom See Plans and Pricing PRODUCT NAME: DABIGATRAN ETEXILATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY DABIGATRAN ETEXILATE MESYLATE; REGISTERED: UK EU/1/08/442/001 20080318; UK EU/1/08/442/002 20080318; UK EU/1/08/442/003 20080318; UK EU/1/08/442/004 20080318; UK EU/1/08/442/005 20080318; UK EU/1/08/442/006 20080318; UK EU/1/08/442/007 20080318; UK EU/1/08/442/008 20080318
2525812 17C1026 France See Plans and Pricing PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151124
0966454 300349 Netherlands See Plans and Pricing 300349, 20180216, EXPIRES: 20230215
1870100 1290025-4 Sweden See Plans and Pricing PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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AstraZeneca
Colorcon
Medtronic
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.