Question 1

Is there a generic for Cobicistat; darunavir ethanolate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cobicistat; darunavir ethanolate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Cobicistat; darunavir ethanolate?

Accepted Answer

PREZCOBIX PED (NDA 220092, JANSSEN PRODS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cobicistat; darunavir ethanolate?

Accepted Answer

The Orange Book lists 4 patents against Cobicistat; darunavir ethanolate 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 Cobicistat; darunavir ethanolate are approved?

Accepted Answer

Cobicistat; darunavir ethanolate is approved in the following dosage forms: tablet, tablet, for suspension.

Product	Applicant	Application	TE	Approved
PREZCOBIX PEDRLD	JANSSEN PRODS	NDA 220092	—	Feb 27, 2026
PREZCOBIXRLD×2	JANSSEN PRODS	NDA 205395	—	Mar 21, 2025

Patent	Expires	In	Type
7700645	Dec 26, 2026	in 6 mo	SubstanceProduct
7700645*PED	Jun 26, 2027	in 1 yr
8148374	Sep 03, 2029	in 3 yr 3 mo	SubstanceProductU-4162
10039718	Oct 06, 2032	in 6 yr 5 mo	Product

Cobicistat; darunavir ethanolate

Brand (NDA) products · tablet, tablet, for suspension

Listed patents (4)

Cobicistat; darunavir ethanolate — frequently asked questions

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