PRADAXA Drug Patent Profile

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When do Pradaxa patents expire, and what generic alternatives are available?

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 11^th, 2020.

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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
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

Drug patent expirations by year for PRADAXA

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

See all PRADAXA clinical trials

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 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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Glossary

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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	214358-005	Jun 21, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	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
>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.

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Country	Patent Number	Title	Estimated Expiration
Austria	430145		⤷ Sign Up
Israel	163863	PHARMACEUTICAL COMPOSITION 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	⤷ Sign Up
Australia	2005318231	Film container	⤷ Sign Up
European Patent Office	1660482	ETHYLESTER-METHANSULFONATE D'ACIDE 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHIL-1H - -BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIQUE ET SON UTILISATION EN TANT QUE MEDICAMENT (3-[(2-{ 4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO] -METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO -PROPIONIC ACID ETHYL ESTER METHANE SULPHONATE AND USE THEREOF AS A MEDICAMENT)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PRADAXA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2525812	32/2017	Austria	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 (MITTEILUNG) 20151124
2525812	17C1026	France	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151124
1870100	132012902065811	Italy	⤷ Sign Up	PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/001-2-3-4-5-6-7-8, 20080318
2525812	2017034	Norway	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description