Pradaxa Drug Patent Profile
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When do Pradaxa patents expire, and when can generic versions of Pradaxa launch?
Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and forty-two patent family members in forty-four countries.
The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pradaxa
A generic version of Pradaxa was approved as dabigatran etexilate mesylate by ALKEM LABS LTD on March 11th, 2020.
Summary for Pradaxa
International Patents: | 142 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 12 |
Clinical Trials: | 55 |
Patent Applications: | 96 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Pradaxa |
Drug Sales Revenues: | Drug sales revenues for Pradaxa |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Pradaxa |
What excipients (inactive ingredients) are in Pradaxa? | Pradaxa excipients list |
DailyMed Link: | Pradaxa at DailyMed |
Recent Clinical Trials for Pradaxa
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | Phase 1 |
Laval University | Phase 2 |
Bayer | Phase 1 |
Pharmacology for Pradaxa
Drug Class | Direct Thrombin Inhibitor |
Mechanism of Action | Thrombin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for Pradaxa
Paragraph IV (Patent) Challenges for PRADAXA
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 Pradaxa
Pradaxa is protected by three US patents and three FDA Regulatory Exclusivities.
Patents protecting Pradaxa
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Patent Expiration: ⤷ Try a Trial
3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting Pradaxa
TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
International Patents for Pradaxa
See the table below for patents covering Pradaxa around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Uruguay | 33196 | ANTIDOTOS DE ANTICOAGULANTES | ⤷ Try a Trial |
European Patent Office | 1485094 | FORME POSOLOGIQUE POUR ADMINISTRATION PAR VOIE ORALE DE L'ETHYLESTER D'ACIDE 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO] PROPIONIQUE OU SES SELS (DOSAGE FORM FOR ORAL ADMINISTRATION OF 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO] PROPIONIC ACID ETHYL ESTER OR ITS SALTS) | ⤷ Try a Trial |
Ukraine | 81760 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ ЭТИЛОВОГО ЭФИРА 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНИЛАМИНОИМИНОМЕТИЛ) ФЕНИЛАМИНО]МЕТИЛ}-1-МЕТИЛ-1Н-БЕНЗИМИДАЗОЛ-5-КАРБОНИЛ)ПИРИДИН-2-ИЛАМИНО]ПРОПИОНОВОЙ КИСЛОТЫ И СПОСОБ ЕЕ ПОЛУЧЕНИЯ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ДЛЯ ПЕРОРАЛЬНОГО ЗАСТОСУВАННЯ ЕТИЛОВОГО ЕФІРУ 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНІЛАМІНОІМІНОМЕТИЛ)ФЕНІЛАМІНО]МЕТИЛ}-1-МЕТИЛ-1Н-БЕНЗІМІДАЗОЛ-5-КАРБОНІЛ)ПІРИДИН-2-ІЛАМІНО]ПРОПІОНОВОЇ КИСЛОТИ ТА СПОСІБ ЇЇ ОДЕРЖАННЯ (Normal;heading 1;heading 2;ADMINISTRATION FORM FOR THE ORAL APPLICATION OF 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO] PROPIONIC ACID ETHYL ESTER AND THE SALTS THEREOF) | ⤷ Try a Trial |
Mexico | PA04008542 | FORMA DE ADMINISTRACION PARA APLICACION ORAL, DE ESTER ETILICO DE ACIDO 3-[(2- {[4 -(HEXILOXICARBONILAMINO -IMINO-METIL) -FINILAMINO] -METIL}-1 -METIL- 1H-BENCIMIDAZOL -5-CARBONIL) -PIRIDIN-2 -IL-AMINO]- PROPIONICO Y SALES DE LA MISMA. (FORM OF PRESENTATION FOR 3- [(2-{[4 -(HEXYLOXYCARBONYLAMINO -IMINO -METHYL)- PHENYLAMINO]- METHYL}- 1-METHYL -1H.) | ⤷ Try a Trial |
Norway | 313879 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Pradaxa
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2525812 | SPC/GB17/044 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IDARUCIZUMAB; REGISTERED: UK EU/1/15/1056 (NI) 20151124; UK PLGB 14598/0220 20151124 |
1870100 | 2012/024 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ETHYL 3-((2-(4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)- PHENYLAMINO)-METHY)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)- PYRIDIN-2-YL-AMINO)-PROPIONATE METHANESULPHONATE |
1870100 | C300538 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318 |
2525812 | PA2017021 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120 |
0966454 | 08C0025 | France | ⤷ Try a Trial | PRODUCT NAME: DABIGATRAN - ETEXILATE ET SES SELS EN PARTICULIER DABIGATRAN ETEXILATE MESILATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/442/001 DU 20080318; REGISTRATION NO/DATE AT EEC: EU/1/08/442/001 DU 20080318 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |