Orange Book product · Brand (NDA)

ZEMBRACE SYMTOUCH

SUMATRIPTAN SUCCINATE

Brand (NDA)NDA 208223RX TONIX MEDS

Jan 28, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 28, 2016
10 yr 7 mo ago
Today
Patent 10537554 expires
Listed method-of-use patent (U-72) expiration.
Jan 29, 2036
in 9 yr 9 mo
Patent 11364224 expires
Listed method-of-use patent (U-72) expiration.
Jan 29, 2036
in 9 yr 9 mo
Patent 12097183 expires
Listed drug product patent expiration.
Jan 29, 2036
in 9 yr 9 mo

Active ingredient

SUMATRIPTAN SUCCINATE

Strength

EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 208223

Product number

001

Marketing status

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
10537554	Jan 29, 2036	in 9 yr 9 mo	U-72
11364224	Jan 29, 2036	in 9 yr 9 mo	U-72
12097183	Jan 29, 2036	in 9 yr 9 mo	Product