Orange Book product · Brand (NDA)

PREZISTA

DARUNAVIR

Brand (NDA)NDA 202895RX JANSSEN PRODS

Dec 16, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 16, 2011
14 yr 9 mo ago
Today
Patent 7700645 expires
Listed drug substance patent expiration.
Dec 26, 2026
in 6 mo
Patent 7700645*PED expires
Listed listed patent expiration.
Jun 26, 2027
in 1 yr

Active ingredient

DARUNAVIR

Strength

100MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 202895

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7700645	Dec 26, 2026	in 6 mo	SubstanceProduct
7700645*PED	Jun 26, 2027	in 1 yr