Question 1

Is there a generic for Atazanavir sulfate; cobicistat?

Accepted Answer

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

Question 2

What is the reference-listed drug for Atazanavir sulfate; cobicistat?

Accepted Answer

EVOTAZ (NDA 206353, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Atazanavir sulfate; cobicistat?

Accepted Answer

The Orange Book lists 2 patents against Atazanavir sulfate; cobicistat products, with the earliest listed expiry in 2029. 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 Atazanavir sulfate; cobicistat are approved?

Accepted Answer

Atazanavir sulfate; cobicistat is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8148374	Sep 03, 2029	in 3 yr 3 mo	SubstanceProductU-1279
10039718	Oct 06, 2032	in 6 yr 5 mo	Product

Atazanavir sulfate; cobicistat

Brand (NDA) products · tablet

Listed patents (2)

Atazanavir sulfate; cobicistat — frequently asked questions

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