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 Number: ⤷ Try a Trial
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
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 | PELLETS;ORAL | 214358-005 | Jun 21, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-006 | Jun 21, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 PRADAXA
See the table below for patents covering PRADAXA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 332209 | ⤷ Try a Trial | |
Uruguay | 27694 | FORMA DE ADMINISTRACIÓN PARA LA APLICACIÓN ORAL DE ÉSTER ETILICO DEL ÁCIDO 3-((2-((4- (HEXILOXICARBONILAMINO-AMINO-METIL)- FENILAMINO)METIL)-1-METIL-1 H -BENCIMIDAZOL-5-CARBONIL)-PIRIDIN-2IL-AMINO)-PROCÍONICO Y LAS SALES DEL MISMO. | ⤷ Try a Trial |
Croatia | P980082 | DISUBSTITUTED BICYCLIC HETEROCYCLES, THEIR PRODUCTION AND USE AS MEDICAMENTS | ⤷ 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 |
---|---|---|---|---|
1870100 | C01870100/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012 |
1485094 | 54/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: DABIGATRANETEXILAT UND SEINE SALZE, INSBESONDERE DABIGATRANETEXILATMESILAT; REGISTRATION NO/DATE: EU/1/08/442/001 - EU1/08/442/008 20080318 |
2525812 | 17C1026 | France | ⤷ Try a Trial | PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151124 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |