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.
Summary for dabigatran etexilate mesylate
International Patents: | 268 |
US Patents: | 5 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 4 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 6 |
Patent Applications: | 490 |
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 |
Generic filers with tentative approvals for DABIGATRAN ETEXILATE MESYLATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 110MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 150MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 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
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
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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