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Last Updated: April 26, 2024

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 freedom to operate?

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim, and is included in five NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dabigatran etexilate mesylate has one hundred and forty-two patent family members in forty-four countries.

There are twenty-four drug master file entries for dabigatran etexilate mesylate. Eight suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for DABIGATRAN ETEXILATE MESYLATE

International Patents:	142
US Patents:	3
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	6
Patent Applications:	303
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DABIGATRAN ETEXILATE MESYLATE
What excipients (inactive ingredients) are in DABIGATRAN ETEXILATE MESYLATE?	DABIGATRAN ETEXILATE MESYLATE excipients list
DailyMed Link:	DABIGATRAN ETEXILATE MESYLATE at DailyMed

Recent Clinical Trials for DABIGATRAN ETEXILATE MESYLATE

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

Sponsor	Phase
Daiichi Sankyo Co., Ltd.	Early Phase 1
Mayo Clinic	Phase 1
Huons Co.,Ltd.	Phase 1

See all DABIGATRAN ETEXILATE MESYLATE clinical trials

Generic filers with tentative approvals for DABIGATRAN ETEXILATE MESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	150MG	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	110MG	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 150MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DABIGATRAN ETEXILATE MESYLATE

Drug Class	Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Medical Subject Heading (MeSH) Categories for DABIGATRAN ETEXILATE MESYLATE

Antithrombins

Paragraph IV (Patent) Challenges for DABIGATRAN ETEXILATE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRADAXA	Capsules	dabigatran etexilate mesylate	eq. to 110 mg base	022512	2	2015-12-15
PRADAXA	Capsules	dabigatran etexilate mesylate	eq. to 75 mg base and 150 mg base	022512	17	2014-10-20

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	PELLETS;ORAL	214358-003	Jun 21, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208040-001	Mar 11, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a 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	Title	Estimated Expiration
Croatia	P20120028		⤷ Try a Trial
Germany	502004009431		⤷ Try a Trial
South Korea	101331039		⤷ Try a Trial
Argentina	045520	METALSULFONATO DE ESTER ETILICO DEL ACIDO 3-[(2-{[4-(HEXILOXI-CARBONILAMINO-IMINO- METIL)-FENILAMINO] - METIL}-1-METIL -1H-BENCIMIDAZOL-5- CARBONIL ) - PIRIDIN -2-IL- AMINO] - PROPIONICO Y SU UTILIZACION COMO MEDICAMENTO	⤷ Try a Trial
Slovenia	2060569		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DABIGATRAN ETEXILATE MESYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2525812	1790034-1	Sweden	⤷ Try a Trial	PRODUCT NAME: IDARUCIZUMAB GODKAENNANDE EU/1/15/1056
0966454	PA2008008	Lithuania	⤷ Try a Trial	PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REG. NO/DATE: EU/1/08/442/001-008 20080509
2525812	CR 2017 00031	Denmark	⤷ Try a Trial	PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
1870100	122012000047	Germany	⤷ Try a 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
1485094	CA 2012 00054	Denmark	⤷ Try a Trial	PRODUCT NAME: DABIGATRAN-ETEXILAT OG SALTENE DERAF; SAERLIGT DABIGATRAN-ETEXILAT-MESYLAT; REG. NO/DATE: EU/1/08/442/009-014 20080318
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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