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PRADAXA Drug 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 one NDA. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and sixty-six patent family members in fifty-two countries.
The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Three 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: | 266 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 31 |
| Clinical Trials: | 51 |
| Patent Applications: | 16 |
| 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 |
|---|---|
| Medical University of Łódź | Phase 4 |
| Voivode Specialist Hospital in Olsztyn, Poland | Phase 4 |
| Military Institute of Medicine, Poland | Phase 4 |
Paragraph IV (Patent) Challenges for PRADAXA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PRADAXA | CAPSULE;ORAL | dabigatran etexilate mesylate | 022512 | 2015-12-15 |
| PRADAXA | CAPSULE;ORAL | dabigatran etexilate mesylate | 022512 | 2014-10-20 |
US Patents and Regulatory Information for PRADAXA
| 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 | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-003 | Nov 20, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-003 | Nov 20, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 529420 | Start Trial |
| Canada | 2277949 | Start Trial |
| Norway | 2017034 | Start Trial |
| Spain | 2380704 | Start Trial |
| Cyprus | 1112796 | Start Trial |
| Portugal | 1485094 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PRADAXA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0966454 | 330 | Finland | Start Trial | |
| 1870100 | 122012000047 | Germany | Start Trial | PRODUCT NAME: DABIGATRAN ETEXILAT MESILAT = 3-((2-((4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)-METHYL)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONSAEURE-ETHYLESTER-METHANSULFONAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318 |
| 1870100 | 00068 | Estonia | Start Trial | |
| 2525812 | 2017/030 | Ireland | Start Trial | PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/15/1056/001 20151120 |
| 1485094 | PA2012021 | Lithuania | Start Trial | PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/009 - EU/1/08/442/014 20110801 |
| 2525812 | PA2017021,C2525812 | Lithuania | Start Trial | PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
