Orange Book product · Brand (NDA)

DHIVY

CARBIDOPA; LEVODOPA

Brand (NDA)NDA 214869RX AVION PHARMS

Nov 12, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 12, 2021
4 yr 8 mo ago
Today
Patent 11033521 expires
Listed drug product patent expiration.
Mar 28, 2039
in 13 yr
Patent 11033521 expires
Listed drug product patent expiration.
Mar 28, 2039
in 13 yr
Patent 11033521 expires
Listed drug product patent expiration.
Mar 28, 2039
in 13 yr
Patent 11439613 expires
Listed method-of-use patent (U-3557) expiration.
Mar 28, 2039
in 13 yr
Patent 11819485 expires
Listed method-of-use patent (U-3557) expiration.
Mar 28, 2039
in 13 yr

Active ingredient

CARBIDOPA; LEVODOPA

Strength

25MG;100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 214869

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
11033521	Mar 28, 2039	in 13 yr	ProductU-219
11033521	Mar 28, 2039	in 13 yr	ProductU-3304
11033521	Mar 28, 2039	in 13 yr	ProductU-3305
11439613	Mar 28, 2039	in 13 yr	U-3557
11819485	Mar 28, 2039	in 13 yr	U-3557