Question 1

Is there a generic for Edoxaban tosylate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Edoxaban tosylate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Edoxaban tosylate?

Accepted Answer

SAVAYSA (NDA 206316, DAIICHI SANKYO INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Edoxaban tosylate?

Accepted Answer

The Orange Book lists 2 patents against Edoxaban tosylate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Edoxaban tosylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Edoxaban tosylate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Edoxaban tosylate are approved?

Accepted Answer

Edoxaban tosylate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7365205	Apr 18, 2027	in 10 mo	Substance
9149532	Mar 28, 2028	in 1 yr 10 mo	Product

Edoxaban tosylate

Brand (NDA) products · tablet

Marketing exclusivity (3)

Listed patents (2)

Edoxaban tosylate — frequently asked questions

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