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Generated: August 21, 2018

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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 fifty-six patent family members in fifty-one countries.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-five 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
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.

Medical Subject Heading (MeSH) Categories for PRADAXA
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-[n-[4-(n-n-hexyloxycarbonylamidino)phenyl]aminomethyl]benzimidazol-5-yl-carboxylic acid-n-(2-pyridyl)-n-(2-ethoxycarbonylethyl)amide
1-methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]-amino-methyl]-benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide
1-methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]-amino-methyl]-benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide mesylate
1-Methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]-aminomethyl]-benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide
1-methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]amino methyl]benzimidazol-5-yl-carboxylicacid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl) amide
1610666-09-5
211915-06-9
2E18WX195X
3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester;
3-[[[2-[[4-[(E)-amino-[hexoxy(oxo)methyl]iminomethyl]anilino]methyl]-1-methyl-5-benzimidazolyl]-oxomethyl]-(2-pyridinyl)amino]propanoic acid ethyl ester
593282-20-3
728P819
872728-81-9
915B069
A815191
AB0028927
AB01274780_02
AB01274780-01
AB01563294_01
AB1008442
AB1008443
AC-22314
AC-26434
AC1O6291
AKOS015900928
AKOS015951090
AKOS015951091
AKOS015994531
AKOS026749886
AM81239
AN-387
BCP9000578
BCPP000269
BDBM50432209
beta-Alanin,N-((2-(((4-((((hexyloxy)carbonyl)amino)iminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-ethylester
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
BIBR 1048 BS RS1
BIBR 1048 MS
BIBR 1048MS
BIBR-1048
BIBR-1048 - Dabigatran etexilate
BIBR-1048 (Dabigatran)
BIBR-1048-BS-RS1
BIBR-1048-MS
BIBR-1048MS
BIBR1048
BS-1001
BS-1008
C34H41N7O5
C34H41N7O5.CH4O3S
CAS-211915-06-9
cc-72
CCG-213236
CD0134
CHEBI:70743
CHEBI:70746
CHEMBL1615369
CHEMBL539697
CP0128
CS-0530
CS-1398
CS-W004358
CTK8E2359
D07082
D07144
Dabigatran etexilate
Dabigatran etexilate (mesylate)
Dabigatran etexilate (USAN/INN)
Dabigatran etexilate [USAN:INN:BAN]
Dabigatran etexilate mesilate
Dabigatran etexilate mesilate (salt form)
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)
DABIGATRAN ETEXILATE; METHANESULFONIC ACID
DB06695
DSSTox_CID_31470
DSSTox_GSID_57681
DSSTox_RID_97355
DTXSID20236248
DTXSID4057681
EBD35035
EC 606-722-8
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
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)amino)iminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)(pyridin-2-yl)amino)propanoate
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-(1-{2-[({4-[(1E)-amino({[(hexyloxy)carbonyl]imino})methyl]phenyl}amino)methyl]-1-methyl-1,3-benzodiazol-5-yl}-N-(pyridin-2-yl)formamido)propanoate
ethyl 3-(1-{2-[({4-[amino({[(hexyloxy)carbonyl]imino})methyl]phenyl}amino)methyl]-1-methyl-1H-1,3-benzodiazol-5-yl}-N-(pyridin-2-yl)formamido)propanoate
ethyl 3-(2-((4-(N-(hexyloxycarbonyl)carbamimidoyl)phenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate
ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazole-5-carbonyl)-pyridin-2-yl-amino]-propionate
ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazole-5-carbonyl)-pyridin-2-yl-amino]-propionate methanesulphonate
Ethyl 3-[[[4-[[[(hexyloxyl)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino] propanoate
Ethyl 3-[[[4-[[[(hexyloxyl)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino] propanoate (INN)
ethyl 3-[[2-[[[4-(N'-hexoxycarbonylcarbamimidoyl)phenyl]amino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate
ethyl 3-[[2-[[[4-[(E)-N'-hexoxycarbonylcarbamimidoyl]phenyl]amino]methyl]-1-methyl-benzimidazol-5-yl]carbonyl-pyridin-2-yl-amino]propanoate
ethyl 3-[[2-[[4-(N-hexoxycarbonylcarbamimidoyl)anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid
ethyl 3-[[2-[[4-[(Z)-N'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate
ethyl N-[(2-{[(4-{N-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-pyridin-2-yl-beta-alaninate
ethyl N-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-pyridin-2-yl-beta-alaninate
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
FT-0650701
FT-0660872
GTPL6379
HE072481
HMS3655H04
HY-10274
HY-10274A
I14-15723
KB-76396
KSGXQBZTULBEEQ-UHFFFAOYSA-N
LP080482
LP114850
MFCD16038312
MLS006010034
MolPort-016-633-287
MolPort-020-006-055
MolPort-020-313-386
MolPort-020-313-389
MolPort-028-747-981
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
N-[2-[4-[N-(Hexyloxycarbonyl)amidino]phenylaminome
N-[2-[4-[N-(Hexyloxycarbonyl)amidino]phenylaminomethyl]-1-methyl-1H-benzimidazol-5-ylcarbonyl]-N-(2-pyridyl)-beta-alanine ethyl ester
NCGC00262929-01
NCGC00262929-02
Pradax
Pradaxa mesylate
Pradaxa, Dabigatran etexilate mesylate
Pradaxa, Pradax, Prazaxa
Prazaxa
Q-102504
Rabigatran etexilate
Rendix
RL02610
S-7728
s2154
SC-85787
SC7NUW5IIT
SCHEMBL1268805
SCHEMBL505829
SMR004701211
ST2412782
STL450990
STL483396
Tox21_113924
UNII-2E18WX195X
UNII-SC7NUW5IIT
W-5683
X1041
X1061
XETBXHPXHHOLOE-UHFFFAOYSA-N
ZINC3943279

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

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

Non-Orange Book US Patents for PRADAXA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,414,008 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions ➤ Try a Free Trial
6,710,055 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions ➤ Try a Free Trial
6,469,039 Disubstituted bicyclic heterocycles, the preparation and the use thereof as pharmaceutical compositions ➤ Try a Free Trial
8,486,398 Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PRADAXA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0882 Netherlands ➤ Try a Free Trial PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056/001 20151124
0538 Netherlands ➤ Try a Free Trial PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2012021 Lithuania ➤ Try a Free Trial PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/009 - EU/1/08/442/014 20110801
2012000047 Germany ➤ Try a Free Trial PRODUCT NAME: DABIGATRAN ETEXILAT MESILAT = 3-((2-((4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)-METHYL)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONSAEURE-ETHYLESTER-METHANSULFONAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2008008,C0966454 Lithuania ➤ Try a Free Trial PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Julphar
Cipla
UBS
Accenture
Cantor Fitzgerald
US Army
McKinsey
Teva

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 verifification 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.