PRADAXA Drug Patent Profile
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Which patents cover Pradaxa, 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. Nine 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: | 4 |
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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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
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Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
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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
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PEDIATRIC EXCLUSIVITY
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NEW PRODUCT
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International Patents for PRADAXA
See the table below for patents covering PRADAXA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 92117 | ⤷ Sign Up | |
Portugal | 1660482 | ⤷ Sign Up | |
Colombia | 5660265 | METANOSULFONATO DEL ESTER ETILICO DEL ACIDO 3-[(2-{[4-(HEXILOXI-CARBONILAMINO-IMINO-METIL)-FENILAMINO]-METIL}-1-METIL-1H-BENCI-MIDAZOL-5-CARBONIL)-PIRIDIN-2-IL-AMINO]-PROPIONICO Y SU UTILIZACION COMO MEDICAMENTO | ⤷ Sign Up |
Taiwan | 200306188 | ⤷ Sign Up | |
Cyprus | 1112796 | ⤷ Sign Up | |
Japan | 2007056018 | MEDICINAL COMPOSITION FOR ORAL ADMINISTRATION CONTAINING 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER OR SALT THEREOF | ⤷ Sign Up |
Estonia | 04716 | Diasendatud bitsüklilised heterotsüklid, nende valmistamine ja kasutamine ravimitena | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRADAXA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1485094 | 54/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: DABIGATRANETEXILAT UND SEINE SALZE, INSBESONDERE DABIGATRANETEXILATMESILAT; REGISTRATION NO/DATE: EU/1/08/442/001 - EU1/08/442/008 20080318 |
1870100 | 300538 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318 |
0966454 | 08C0025 | France | ⤷ Sign Up | 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 |
1485094 | 132012902112338 | Italy | ⤷ Sign Up | PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/009-011-012-013-014, 20110801 |
2525812 | 17C1026 | France | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151124 |
1870100 | 1290025-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318 |
0966454 | CA 2008 00032 | Denmark | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |