Orange Book product · Brand (NDA)

ONYDA XR

CLONIDINE HYDROCHLORIDE

Brand (NDA)NDA 217645RX TRIS PHARMA INC

May 24, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 24, 2024
2 yr 1 mo ago
Today
Patent 8062667 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo
Patent 11918689 expires
Listed drug product patent expiration.
Jul 28, 2041
in 15 yr 4 mo
Patent 12576032 expires
Listed method-of-use patent (U-2357) expiration.
Jul 28, 2041
in 15 yr 4 mo

Active ingredient

CLONIDINE HYDROCHLORIDE

Strength

0.1MG/ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 217645

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
8062667	Mar 29, 2029	in 2 yr 10 mo	Product
11918689	Jul 28, 2041	in 15 yr 4 mo	ProductU-3944
12576032	Jul 28, 2041	in 15 yr 4 mo	U-2357