PRADAXA Drug Patent Profile
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Which patents cover Pradaxa, and what generic alternatives are available?
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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Summary for PRADAXA
| International Patents: | 120 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| 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 |
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.
Patents protecting PRADAXA
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
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Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
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NEW PRODUCT
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| 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 | 214358-006 | Jun 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-006 | Jun 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-002 | Jun 21, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-004 | Jun 21, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-003 | Nov 20, 2015 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|
| South Africa | 200600518 | 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-MENTHYL}-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDINE-2-YL-AMINO]-PROPIONIX ACID ETHYL ESTER METHANE SULPHONATE AND USE THEREOF AS A MEDICAMENT | ⤷ Sign Up |
| Netherlands | 300882 | ⤷ Sign Up | |
| Norway | 334115 | ⤷ Sign Up | |
| Norway | 313879 | ⤷ Sign Up | |
| Norway | 332209 | ⤷ Sign Up | |
| Ecuador | SP082418 | HETEROCICLOS BICICLICOS DISUSTITUIDOS, SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB; REGISTERED: UK EU/1/15/1056 (NI) 20151124; UK PLGB 14598/0220 20151124 |
| 1485094 | 00122 | Estonia | ⤷ Sign Up | |
| 1870100 | CA 2012 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318 |
| 1870100 | 4/2013 | Austria | ⤷ Sign Up | PRODUCT NAME: DIBIGATRANEXILAT (MESYLAT); REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318 |
| 2525812 | C20170024 | Estonia | ⤷ Sign Up | PRODUCT NAME: IDARUTSIZUMAB; NATIONAL AUTHORISATION NUMBER: EMA/490612/2020 16.09.2020 |
| 2525812 | 1790034-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB GODKAENNANDE EU/1/15/1056 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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