Pharsight

Pradaxa generic

Pradaxa is approved to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE). It is owned by Boehringer Ingelheim. It contains the active ingredient Dabigatran Etexilate Mesylate. It was first authorized for medical use in 2010. The global anticoagulants market size was estimated at US$ 28 billion in 2022 and it is projected to surpass around US$ 67 billion by 2032. There were 9 drug patents protecting Pradaxa in United States, but as of now 2 of those patents have expired.

When will Pradaxa generic be available?

Pradaxa (Dabigatran Etexilate Mesylate) currently had patent protection until July 20, 2031. This means Pradaxa will be available in the market after July 20, 2031, unless a Paragraph IV certification was filed challenging the patents before expiration.

Pradaxa uses

Pradaxa is an anticoagulant medication approved for use in adults to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). The active ingredient in Pradaxa is Dabigatran Etexilate Mesylate, which works by preventing the formation of blood clots.

Pradaxa patent expiration

Pradaxa currently holds 9 patents covering various aspects, including the active ingredient and formulation. The main drug substance patent will expire in September 2025, marking a significant milestone for the medication. With patents lasting over 8 more years, patent expiration will prevent Pradaxa generic until 20 July, 2031. Below is a list of the recent Pradaxa patent expirations -

EPO Oppostions filed on Pradaxa

Pradaxa dosage

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