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Last Updated: April 23, 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	214358-004	Jun 21, 2021		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	022512-001	Oct 19, 2010	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-006	Jun 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-005	Jun 21, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ 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
Japan	5575923		⤷ Try a Trial
Cyprus	1118875		⤷ Try a Trial
Lithuania	C2525812		⤷ Try a Trial
Luxembourg	C00028		⤷ Try a Trial
Hungary	E032263		⤷ Try a Trial
Austria	430145		⤷ 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	C20170024 00247	Estonia	⤷ Try a Trial	PRODUCT NAME: IDARUTSIZUMAB;REG NO/DATE: EU/1/15/1056 24.11.2015
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
2525812	CA 2017 00031	Denmark	⤷ Try a Trial	PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
1870100	132012902065811	Italy	⤷ Try a Trial	PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/001-2-3-4-5-6-7-8, 20080318
2525812	2017034	Norway	⤷ Try a Trial	PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124
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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