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 two patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and twenty 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. Twelve 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.
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Questions you can ask:
- What is the 5 year forecast for PRADAXA?
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- What is Average Wholesale Price for PRADAXA?
Summary for PRADAXA
International Patents: | 120 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 12 |
Clinical Trials: | 55 |
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 |
![PRADAXA drug patent expirations Drug patent expirations by year for PRADAXA](/p/graph/s/t/PRADAXA-patent-expirations.png)
![Drug Prices for PRADAXA](/p/graph/drug-price/PRADAXA.png)
![Drug Sales Revenue Trends for PRADAXA](/p/graph/drug-sales-revenues/PRADAXA.png)
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 |
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 two US patents and three FDA Regulatory Exclusivities.
International Patents for PRADAXA
See the table below for patents covering PRADAXA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
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 for Free |
Luxembourg | 92117 | ⤷ Try for Free | |
Malaysia | 145696 | 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-MENTHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYLESTER-METHANESULFONATE AND ITS USE AS A MEDICAMENT | ⤷ Try for Free |
New Zealand | 578586 | 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridine-2-yl-amino]-propionic acid ethyl ester methane sulphonate and use thereof as a medicament | ⤷ Try for Free |
Peru | 20050348 | METANOSULFONATO DEL ESTER ETILICO DEL ACIDO 3-[ (2-{ [4-(HEXILOXICARBONILAMINO-IMINO-METIL)-FENILAMINO]-METIL} -1-METIL-1H-BENCIMIDAZOL-5-CARBONIL)-PIRIDIN-2-IL-AMINO] -PROPIONICO | ⤷ Try for Free |
Taiwan | I418553 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2006067096 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRADAXA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1485094 | 122012000103 | Germany | ⤷ Try for Free | PRODUCT NAME: DABIGATRANETEXILAT-MESYLAT; REGISTRATION NO/DATE: EU/1/08/442/009-014 20110801 |
1870100 | 1290025-4 | Sweden | ⤷ Try for Free | PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318 |
2525812 | 2017034 | Norway | ⤷ Try for Free | PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124 |
1485094 | C20120023 00122 | Estonia | ⤷ Try for Free | PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008 |
1870100 | CA 2012 00027 | Denmark | ⤷ Try for Free | PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318 |
2525812 | CR 2017 00031 | Denmark | ⤷ Try for Free | PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124 |
2525812 | SPC/GB17/044 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: IDARUCIZUMAB; REGISTERED: UK EU/1/15/1056 (NI) 20151124; UK PLGB 14598/0220 20151124 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of PRADAXA
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