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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 dabigatran etexilate mesylate freedom to operate?

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.

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

Summary for dabigatran etexilate mesylate

US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	26
Suppliers / Packagers:	2
Bulk Api Vendors:	33
Clinical Trials:	3
Patent Applications:	18
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

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-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

AKOS015951091

AKOS015994531

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-1398

CS-W004358

D07082

Dabigatran etexilate (mesylate)

Dabigatran etexilate mesilate

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

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

FT-0660872

HY-10274A

KB-76396

LP114850

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

Pradaxa mesylate

Pradaxa, Dabigatran etexilate mesylate

Prazaxa

Rendix

SC7NUW5IIT

SCHEMBL1268805

UNII-SC7NUW5IIT

W-5683

X1061

XETBXHPXHHOLOE-UHFFFAOYSA-N

US Patents and Regulatory Information for dabigatran etexilate mesylate

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	022512-003	Nov 20, 2015		RX	Yes	No			Y		Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015		RX	Yes	No			Y	Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010		RX	Yes	Yes			Y		Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-001	Oct 19, 2010		RX	Yes	No			Y	Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010		RX	Yes	Yes			Y	Y

International Patents for dabigatran etexilate mesylate

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005028468
Denmark	1870100
Poland	335154
Norway	326918
Mexico	2012008360
Serbia	52088

Supplementary Protection Certificates for dabigatran etexilate mesylate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0	Finland
19/2008	Austria		PRODUCT NAME: DABIGATRANETEXILAT UND DESSEN SALZE, INSBESONDERE DABIGATRANETEXILAT-MESILAT
90025-4	Sweden		PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318
2017 00031	Denmark		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2017 00031	Denmark		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2012021	Lithuania		PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/009 - EU/1/08/442/014 20110801