Question 1

Is there a generic for Simvastatin; sitagliptin phosphate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Simvastatin; sitagliptin phosphate?

Accepted Answer

JUVISYNC (NDA 202343, MERCK SHARP DOHME) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Simvastatin; sitagliptin phosphate?

Accepted Answer

The Orange Book lists 2 patents against Simvastatin; sitagliptin phosphate products, with the earliest listed expiry in 2026. 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 Simvastatin; sitagliptin phosphate are approved?

Accepted Answer

Simvastatin; sitagliptin phosphate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7326708	Apr 11, 2026	2 mo ago	SubstanceProductU-1188
7326708*PED	Oct 11, 2026	in 4 mo

Simvastatin; sitagliptin phosphate

Brand (NDA) products · tablet

Listed patents (2)

Simvastatin; sitagliptin phosphate — frequently asked questions

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