Question 1

Is there a generic for Ertugliflozin; metformin hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ertugliflozin; metformin hydrochloride?

Accepted Answer

SEGLUROMET (NDA 209806, MSD SUB MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ertugliflozin; metformin hydrochloride?

Accepted Answer

The Orange Book lists 3 patents against Ertugliflozin; metformin hydrochloride products, with the earliest listed expiry in 2030. 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

What dosage forms of Ertugliflozin; metformin hydrochloride are approved?

Accepted Answer

Ertugliflozin; metformin hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9439902	Oct 21, 2030	in 4 yr 5 mo	U-2214
9308204	Oct 21, 2030	in 4 yr 5 mo	Product
8080580	Dec 19, 2031	in 5 yr 7 mo	SubstanceProductU-2214

Ertugliflozin; metformin hydrochloride

Brand (NDA) products · tablet

Listed patents (3)

Ertugliflozin; metformin hydrochloride — frequently asked questions

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