Dabigatran etexilate mesylate - Generic Drug Details

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What are the generic drug sources for dabigatran etexilate mesylate and what is the scope of patent protection?

Dabigatran etexilate mesylate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dabigatran etexilate mesylate has two hundred and sixty-two patent family members in fifty-one countries.

There are twenty-six drug master file entries for dabigatran etexilate mesylate. Two suppliers are listed for this compound.

Summary for dabigatran etexilate mesylate

International Patents:	262
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	26
Suppliers / Packagers:	2
Bulk Api Vendors:	57
Clinical Trials:	5
Patent Applications:	88
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dabigatran etexilate mesylate
DailyMed Link:	dabigatran etexilate mesylate at DailyMed

Recent Clinical Trials for dabigatran etexilate mesylate

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Sponsor	Phase
Mayo Clinic	Phase 1
Huons Co.,Ltd.	Phase 1
Janssen Research & Development, LLC	Phase 1

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Recent Litigation for dabigatran etexilate mesylate

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District Court Litigation

Case Name	Date
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

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Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate

Antithrombins

Synonyms for dabigatran etexilate mesylate

(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
211915-06-9
593282-20-3
728P819
AB1008443
AC-26434
AKOS015951091
AKOS015994531
AKOS026749886
BCP02864
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
CD0134
CHEBI:70743
CHEMBL1615369
CP0128
CS-W004358
CTK8E2359
D07082
Dabigatran etexilate
Dabigatran etexilate (mesylate)
Dabigatran etexilate mesilate
Dabigatran etexilate meslate
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
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)phenyl]amino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate
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-0650701
FT-0660872
GTPL6379
HMS3655H04
KB-76396
KSGXQBZTULBEEQ-UHFFFAOYSA-N
MLS006010034
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
NCGC00262929-02
Pradaxa
Pradaxa (TN)
Pradaxa mesylate
Pradaxa, Dabigatran etexilate mesylate
Prazaxa
Rendix
SB19226
SC7NUW5IIT
SCHEMBL1268805
SMR004701211
SW219397-1
UNII-SC7NUW5IIT
W-5683
X1061
XETBXHPXHHOLOE-UHFFFAOYSA-N
ZINC3943279

US Patents and Regulatory Information for dabigatran etexilate mesylate

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Glossary

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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	Y	Y		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	022512-003	Nov 20, 2015		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
>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 dabigatran etexilate mesylate

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Country	Patent Number	Estimated Expiration
Luxembourg	92117	Start Trial
Ukraine	81760	Start Trial
Israel	184086	Start Trial
Slovenia	2525812	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for dabigatran etexilate mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0966454	CA 2008 00032	Denmark	Start Trial
2525812	PA2017021,C2525812	Lithuania	Start Trial	PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120
0966454	91437	Luxembourg	Start Trial	91437, EXPIRES: 20230216
1485094	54/2012	Austria	Start Trial	PRODUCT NAME: DABIGATRANETEXILAT UND SEINE SALZE, INSBESONDERE DABIGATRANETEXILATMESILAT; REGISTRATION NO/DATE: EU/1/08/442/001 - EU1/08/442/008 20080318
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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