PRADAXA Drug Patent Profile

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. Fourteen 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.

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

See drug prices for PRADAXA

See drug sales revenues 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 two US patents.

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	7,932,273*PED				Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015	AB	RX	Yes	No	7,932,273*PED				Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-001	Jun 21, 2021		RX	Yes	No	7,932,273*PED				Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-002	Jun 21, 2021		RX	Yes	No	7,932,273*PED				Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-006	Jun 21, 2021		RX	Yes	Yes	7,932,273*PED				Y

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)
Luxembourg	91437
New Zealand	535663	Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino] propionic acid ethyl ester and the salts thereof
Norway	20130778
Portugal	1485094

Supplementary Protection Certificates for PRADAXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1485094	132012902112338	Italy		PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/009-011-012-013-014, 20110801
1485094	92117	Luxembourg
2525812	C201730027	Spain		PRODUCT NAME: IDARUCIZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1056; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1056; DATE OF FIRST AUTHORISATION IN EEA: 20151120
2525812	CR 2017 00031	Denmark		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2525812	PA2017021,C2525812	Lithuania		PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120

Market Dynamics and Financial Trajectory of PRADAXA

Introduction

PRADAXA, also known as dabigatran etexilate, is a direct thrombin inhibitor developed by Boehringer Ingelheim. It has been a significant player in the anticoagulant market since its introduction. Here, we will delve into the market dynamics and financial trajectory of PRADAXA, highlighting its key milestones, challenges, and current status.

Early Success and Market Entry

PRADAXA was one of the first new-generation anticoagulants to enter the market, providing an alternative to the traditional anticoagulant warfarin. Its launch was highly successful, with the drug achieving blockbuster status shortly after its introduction. In 2011, PRADAXA generated €629 million ($831 million) in sales, marking one of the most successful market introductions in the pharmaceutical industry at the time[1].

Sales Growth and Market Position

By 2012, PRADAXA had already demonstrated substantial growth, contributing significantly to Boehringer Ingelheim's revenue. The drug's sales grew by 13% in 2012, helping the company achieve overall sales of €13.2 billion ($17.4 billion) and a 66% increase in profits[1].

In the subsequent years, PRADAXA continued to perform well. By 2013, its sales had increased by nearly 9% in euro terms, reaching €1.2 billion. This growth was crucial in offsetting the decline in sales of other Boehringer Ingelheim products due to currency effects and patent expirations[2].

Competitive Landscape

The anticoagulant market is highly competitive, with several other drugs vying for market share. PRADAXA faced competition from other new-generation anticoagulants such as Xarelto (rivaroxaban) from Bayer and Johnson & Johnson, and Eliquis (apixaban) from Pfizer and Bristol-Myers Squibb.

Despite being the first to market, PRADAXA eventually faced challenges from its competitors. Xarelto, in particular, gained a strong market position with six indications, allowing it to lead the market. However, PRADAXA continued to hold its ground, especially with additional FDA approvals for treating deep vein thrombosis (DVT) and pulmonary embolism (PE)[2].

Safety Concerns and Legal Challenges

PRADAXA has been associated with safety concerns, particularly regarding bleeding risks. This led to numerous liability lawsuits, with over 2,000 cases pending in U.S. courts. These safety issues and legal challenges have impacted the drug's market performance and public perception[2].

Global Market Trends

The global anticoagulant market has seen significant changes over the years. According to IMS data, the global market sales of anti-thrombotic drugs, including PRADAXA, were $23.5 billion in 2013. Direct thrombin inhibitors like PRADAXA accounted for 10.4% of these sales, with PRADAXA leading this category[4].

The market has continued to evolve, with direct coagulation factor Xa inhibitors like rivaroxaban and apixaban gaining ground. However, PRADAXA remains a key player, especially in regions where it has established a strong presence.

Financial Performance in Recent Years

In recent years, PRADAXA's sales have stabilized but not grown at the same rate as in its early years. In 2020, PRADAXA generated €1,492 million in sales, which was marginally lower than the previous year's result. This reflects the competitive pressures and the maturing of the anticoagulant market[5].

Regional Performance

PRADAXA's sales performance varies by region. The drug has been particularly strong in key markets such as the U.S., Germany, and Japan. However, currency fluctuations and regional market dynamics have impacted its overall sales. For instance, a weak U.S. dollar and Japanese yen affected Boehringer Ingelheim's sales in 2013, despite PRADAXA's growth[2].

Future Outlook

The future outlook for PRADAXA is influenced by several factors, including the competitive landscape, regulatory environment, and ongoing safety monitoring. While it may not be the leading anticoagulant in terms of sales, PRADAXA remains a significant player in the market.

As the anticoagulant market continues to evolve, PRADAXA will need to adapt to new challenges and opportunities. This includes expanding its indications, improving patient safety profiles, and navigating the complexities of a highly competitive market.

Key Takeaways

• Early Success: PRADAXA achieved blockbuster status shortly after its launch.
• Sales Growth: The drug saw significant sales growth in its early years, contributing substantially to Boehringer Ingelheim's revenue.
• Competitive Landscape: PRADAXA faces intense competition from other new-generation anticoagulants.
• Safety Concerns: The drug has been associated with safety issues, particularly bleeding risks, leading to legal challenges.
• Global Market Trends: PRADAXA remains a key player in the global anticoagulant market, despite evolving market dynamics.
• Financial Performance: Recent sales have stabilized but are not growing at the same rate as in the early years.
• Regional Performance: The drug's sales vary by region, influenced by currency fluctuations and local market conditions.

FAQs

What was the initial market response to PRADAXA?

PRADAXA received a highly positive initial market response, achieving blockbuster status shortly after its launch and contributing significantly to Boehringer Ingelheim's revenue growth.

How does PRADAXA compare to other anticoagulants in the market?

PRADAXA faces strong competition from other new-generation anticoagulants like Xarelto and Eliquis. While it was the first to market, it has since been overtaken by Xarelto in terms of market share and indications.

What safety concerns have been associated with PRADAXA?

PRADAXA has been associated with safety concerns, particularly regarding bleeding risks, which have led to numerous liability lawsuits.

How has PRADAXA's sales performance been in recent years?

In recent years, PRADAXA's sales have stabilized but not grown at the same rate as in its early years. In 2020, it generated €1,492 million in sales, marginally lower than the previous year.

What are the key factors influencing PRADAXA's future outlook?

The future outlook for PRADAXA is influenced by the competitive landscape, regulatory environment, ongoing safety monitoring, and the need to expand its indications and improve patient safety profiles.

Sources

1. FiercePharma: "Pradaxa hits blockbuster mark, swelling Boehringer sales"[1]
2. FiercePharma: "Boehringer Ingelheim revenue slide cushioned by Pradaxa sales jump"[2]
3. Pfizer Inc.: "Q3 2015 Pfizer Inc Earnings Call"[3]
4. Journal of Thoracic Disease: "Recent progress and market analysis of anticoagulant drugs"[4]
5. Boehringer Ingelheim: "2020 Annual Report Summary"[5]