Edoxaban manufacturers

About edoxaban

Edoxaban manufacturers include the originator Daiichi Sankyo, which sells it as Lixiana (Japan, EU, Asia) and Savaysa (US), and generic companies preparing launches as the compound patent expires, starting with Korea in November 2026. Edoxaban is a once-daily oral factor Xa inhibitor (direct oral anticoagulant, DOAC). It prevents stroke in atrial fibrillation and treats and prevents venous thromboembolism. Pharmaceutical companies can source edoxaban tablets and API through out-licensing, supply or technology transfer.

Edoxaban key facts

Edoxaban manufacturers and licensing history

Daiichi Sankyo developed edoxaban and first launched it in Japan in 2011 as Lixiana. The FDA approved it as Savaysa in January 2015, and the EU approved Lixiana in 2015. Edoxaban is the market-leading DOAC in Korea and Japan, and it is widely used in Europe.

In Korea, the compound patent expires on 10 November 2026. More than ten companies, including Boryung, Hanmi and Chong Kun Dang, have designed around the formulation patent, and many generic products are approved and expected to launch from 11 November 2026.

Edoxaban generics are being prepared for other markets as patents expire. Buyers should confirm the salt form (tosilate or other), GMP status, a DMF and freedom to operate in each target country before choosing a dossier partner.

Edoxaban dosage forms and dossier types

Edoxaban is approved as 15, 30 and 60 mg film-coated tablets. Generic manufacturers develop all three strengths.

Edoxaban regulatory and patent status

Edoxaban was approved in Japan in 2011, and in the US and EU in 2015. In Korea, generics are expected from 11 November 2026, after the compound patent expires. A formulation patent runs to August 2028, but many companies have designed around it. Check SPCs, Orange Book patents and national registers before filing in other markets.

Edoxaban mechanism of action and therapeutic use

Edoxaban directly blocks factor Xa, a key enzyme in blood clotting. This reduces thrombin production and prevents clots from forming. Edoxaban is taken once daily to prevent stroke in atrial fibrillation and to treat or prevent deep vein thrombosis and pulmonary embolism. Dose reduction is needed in kidney impairment and low body weight.

Edoxaban licensing and sourcing

Edoxaban suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), salt form, patent position and territory availability. Current offers and supplier contacts are listed among the edoxaban manufacturers on Pipelinepharma.

Frequently asked questions about edoxaban

Who are the main edoxaban manufacturers? Daiichi Sankyo is the originator and sells Lixiana and Savaysa. In Korea, many generic companies, including Boryung, Hanmi and Chong Kun Dang, are preparing launches.

When does the edoxaban patent expire? In Korea, the compound patent expires on 10 November 2026. Expiry dates in other markets differ, so check national registers.

Is an edoxaban dossier available for licensing? Yes. Edoxaban 15, 30 and 60 mg tablet dossiers are being developed in EU CTD and other formats.

What forms and strengths of edoxaban are available? Edoxaban is available as 15, 30 and 60 mg film-coated tablets.

What is the difference between Lixiana and Savaysa? They contain the same drug. Savaysa is the US brand name, and Lixiana is used in Japan, Europe and Asia.