Orange Book product · Brand (NDA)

EMROSI

MINOCYCLINE HYDROCHLORIDE

Brand (NDA)NDA 219015RX JOURNEY

Nov 01, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 01, 2024
1 yr 8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Nov 01, 2027
in 1 yr 5 mo
Patent 10905664 expires
Listed method-of-use patent (U-4043) expiration.
Jan 07, 2039
in 12 yr 9 mo
Patent 11191740 expires
Listed method-of-use patent (U-4043) expiration.
Jan 07, 2039
in 12 yr 9 mo
Patent 11364212 expires
Listed method-of-use patent (U-4043) expiration.
Jan 07, 2039
in 12 yr 9 mo
Patent 12594252 expires
Listed method-of-use patent (U-4043) expiration.
Jan 07, 2039
in 12 yr 9 mo

Active ingredient

MINOCYCLINE HYDROCHLORIDE

Strength

EQ 40MG BASE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 219015

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
10905664	Jan 07, 2039	in 12 yr 9 mo	U-4043
11191740	Jan 07, 2039	in 12 yr 9 mo	U-4043
11364212	Jan 07, 2039	in 12 yr 9 mo	U-4043
12594252	Jan 07, 2039	in 12 yr 9 mo	U-4043