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Last Updated: March 29, 2020

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PRADAXA Drug 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 one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and sixty-six 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. Additional details are available on the dabigatran etexilate mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Pradaxa

Pradaxa was eligible for patent challenges on October 19, 2014.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 7, 2025. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $677mm indicating the motivation for generic entry (peak sales were $1.2bn in 2014).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (dabigatran etexilate mesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for PRADAXA
Drug Prices for PRADAXA

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Drug Sales Revenue Trends for PRADAXA

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Generic Entry Opportunity Date for PRADAXA
Generic Entry Date for PRADAXA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PRADAXA

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

SponsorPhase
Population Health Research InstitutePhase 4
The University of Hong KongPhase 4
University of ZurichPhase 3

See all PRADAXA clinical trials

Recent Litigation for PRADAXA

Identify potential future generic entrants

District Court Litigation
Case NameDate
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG v. HETERO USA, INC.2016-04-26
Boehringer Ingelheim Pharma GmbH & Co. KG v. Teva Pharmaceuticals USA Inc.2015-01-16
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG v. TEVA PHARMACEUTICALS USA, INC.2014-12-15

See all PRADAXA litigation

Synonyms for PRADAXA
(Z)-ethyl 3-(2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate methanesulfonate
1-methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]-amino-methyl]-benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide mesylate
593282-20-3
728P819
872728-81-9
AB1008443
AC-26434
AKOS015994531
BCP06644
BIBR-1048MS
BS-1008
C34H41N7O5.CH4O3S
CCG-213236
CHEBI:70743
CP0128
CS-W004358
D07082
Dabigatran etexilate (mesylate)
Dabigatran etexilate mesilate
Dabigatran etexilate meslate
Dabigatran etexilate mesylate
Dabigatran etexilate mesylate (USAN)
Dabigatran etexilate mesylate; N-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-|A-alanine ethyl ester monomethanesulfonat
Dabigatran etexilate methanesulfonate
Dabigatran etexilate methanesulfonate (JAN)
DTXSID20236248
ethyl (Z)-3-(2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate methanesulfonate
ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazole-5-carbonyl)-pyridin-2-yl-amino]-propionate methanesulphonate
ethyl N-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-pyridin-2-yl-beta-alaninate methanesulfonate
EX-A1966
FT-0660872
Pradaxa (TN)
Pradaxa mesylate
Pradaxa, Dabigatran etexilate mesylate
Prazaxa
Rendix
SB19226
SCHEMBL1268805
W-5683
X1061
XETBXHPXHHOLOE-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for PRADAXA
Tradename Dosage Ingredient NDA Submissiondate
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2015-12-15
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2014-10-20

US Patents and Regulatory Information for PRADAXA

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 CAPSULE;ORAL 022512-001 Oct 19, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-001 Oct 19, 2010 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PRADAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2525812 122017000046 Germany   Start Trial PRODUCT NAME: LDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151120
1870100 C01870100/01 Switzerland   Start Trial PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
1485094 CA 2012 00054 Denmark   Start Trial PRODUCT NAME: DABIGATRAN-ETEXILAT OG SALTENE DERAF; SAERLIGT DABIGATRAN-ETEXILAT-MESYLAT; REG. NO/DATE: EU/1/08/442/009-014 20080318
1870100 C20120013 00068 Estonia   Start Trial PRODUCT NAME: PRADAXA - DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 18.03.2008
0966454 C00966454/01 Switzerland   Start Trial PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Dow
AstraZeneca
Colorcon
Medtronic
Baxter

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.