Orange Book product · Brand (NDA)

ATRIPLA

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand (NDA)NDA 021937DISCN GILEAD SCIENCES

Jul 12, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 12, 2006
20 yr 3 mo ago
Patent 9018192 expires
Listed method-of-use patent (U-750) expiration.
Jun 13, 2026
6 d ago
Patent 9018192 expires
Listed method-of-use patent (U-1170) expiration.
Jun 13, 2026
6 d ago
Patent 9545414 expires
Listed drug product patent expiration.
Jun 13, 2026
6 d ago
Patent 9545414 expires
Listed drug product patent expiration.
Jun 13, 2026
6 d ago
Today
Patent 8598185 expires
Listed drug product patent expiration.
Apr 28, 2029
in 2 yr 11 mo

Active ingredient

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Strength

600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 021937

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
9018192	Jun 13, 2026	6 d ago	U-750
9018192	Jun 13, 2026	6 d ago	U-1170
9545414	Jun 13, 2026	6 d ago	ProductU-1170
9545414	Jun 13, 2026	6 d ago	ProductU-750
8598185	Apr 28, 2029	in 2 yr 11 mo	Product