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Last Updated: February 3, 2023

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, Hetero Labs Ltd Iii, and Boehringer Ingelheim, and is included in four NDAs. 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-eight patent family members in fifty-two countries.

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

Recent Clinical Trials for dabigatran etexilate mesylate

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

SponsorPhase
Daiichi Sankyo Co., Ltd.Early Phase 1
Mayo ClinicPhase 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
See Plans and PricingSee Plans and Pricing110MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing150MGCAPSULE;ORAL
See Plans and PricingSee Plans and PricingEQ 150MG BASECAPSULE;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
Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate
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

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-005 Jun 21, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-002 Jun 21, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Country Patent Number Title Estimated Expiration
Ukraine 95601 МЕТАНСУЛЬФОНАТ ЭТИЛОВОГО ЭФИРА 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНИЛАМИНОИМИНОМЕТИЛ)ФЕНИЛАМИНО]МЕТИЛ}-1МЕТИЛ-1Н- БЕНЗИМИДАЗОЛ-5-КАРБОНИЛ)ПИРИДИН-2-ИЛАМИНО]ПРОПИОНОВОЙ КИСЛОТЫ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕГО СОДЕРЖИТ;МЕТАНСУЛЬФОНАТ ЕТИЛОВОГО ЕФІРУ 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНІЛАМІНОІМІНОМЕТИЛ)ФЕНІЛАМІНО]МЕТИЛ}-1МЕТИЛ-1Н-БЕНЗИМІДАЗОЛ-5-КАРБОНІЛ)ПІРИДИН-2-ІЛАМІНО]ПРОПІОНОВОЇ КИСЛОТИ ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЙОГО МІСТИТЬ (3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER-METHANESULPHONATE AND PHARMACEUTICAL COMPOSITION COMPRISING THEREOF) See Plans and Pricing
Germany 122008000020 See Plans and Pricing
Austria 430145 See Plans and Pricing
Taiwan 200512206 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazol-5-carbonyl)-pyridin-2-yl-amion]-propionic acid ethylester-methanesulfonate and its use as a medicament See Plans and Pricing
Portugal 2525812 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dabigatran etexilate mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2525812 CR 2017 00031 Denmark See Plans and Pricing PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
1485094 132012902112338 Italy See Plans and Pricing PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/009-011-012-013-014, 20110801
1485094 C20120023 00122 Estonia See Plans and Pricing PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008
2525812 32/2017 Austria See Plans and Pricing PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 (MITTEILUNG) 20151124
1870100 C01870100/01 Switzerland See Plans and Pricing PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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