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Last Updated: October 17, 2019

DrugPatentWatch Database Preview

PRADAXA Drug Profile

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Which patents cover Pradaxa, and what generic alternatives are available?

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-two patent family members in fifty-one countries.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Two 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

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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
University of ZurichPhase 3
The University of Hong KongPhase 4
Laval UniversityPhase 2

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
AB1008443
AC-26434
AKOS015951091
AKOS015994531
BCP06644
beta-Alanine, N-((2-(((4-((((hexyloxy)carbonyl)amino)iminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-, ethyl ester, methanesulfonate
BIBR 1048 MS
BIBR 1048MS
BIBR-1048
BIBR-1048-MS
BIBR-1048MS
BS-1008
C34H41N7O5.CH4O3S
CCG-213236
CHEBI:70743
CHEMBL1615369
CP0128
CS-W004358
D07082
Dabigatran etexilate (mesylate)
Dabigatran etexilate mesilate
Dabigatran etexilate meslate
Dabigatran etexilate mesylate
Dabigatran etexilate mesylate (USAN)
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-(((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)(pyridin-2-yl)amino)propanoate, methanesulfonate
ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazole-5-carbonyl)-pyridin-2-yl-amino]-propionate methanesulphonate
ethyl 3-[[2-[[4-(N-hexoxycarbonylcarbamimidoyl)anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid
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
KB-76396
MolPort-020-313-389
N-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-|A-alanine Ethyl Ester Methanesulfonate
Pradaxa (TN)
Pradaxa mesylate
Pradaxa, Dabigatran etexilate mesylate
Rendix
SB19226
SC7NUW5IIT
SCHEMBL1268805
UNII-SC7NUW5IIT
W-5683
X1061
XETBXHPXHHOLOE-UHFFFAOYSA-N

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
Paragraph IV (Patent) Challenges for PRADAXA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules eq. to 110 mg base ➤ Subscribe   Start Trial
➤ Subscribe Capsules eq. to 75 mg base and 150 mg base ➤ Subscribe   Start Trial

Supplementary Protection Certificates for PRADAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2525812 PA2017021 Lithuania   Start Trial PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120
0966454 CA 2008 00032 Denmark   Start Trial
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
2525812 C20170024 00247 Estonia   Start Trial PRODUCT NAME: IDARUTSIZUMAB;REG NO/DATE: EU/1/15/1056 24.11.2015
2525812 1790034-1 Sweden   Start Trial PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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