Orange Book product · Brand (NDA)

VASOSTRICT

VASOPRESSIN

Brand (NDA)NDA 204485TE APRX PH HEALTH

Apr 17, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 17, 2014
12 yr 4 mo ago
Today
Patent 9375478 expires
Listed method-of-use patent (U-1857) expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 9687526 expires
Listed method-of-use patent (U-1857) expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 9744209 expires
Listed method-of-use patent (U-1857) expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 9744239 expires
Listed method-of-use patent (U-1857) expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 9750785 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo

Active ingredient

VASOPRESSIN

Strength

20UNITS/ML (20UNITS/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 204485

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
9375478	Jan 30, 2035	in 8 yr 9 mo	U-1857
9687526	Jan 30, 2035	in 8 yr 9 mo	U-1857
9744209	Jan 30, 2035	in 8 yr 9 mo	U-1857
9744239	Jan 30, 2035	in 8 yr 9 mo	U-1857
9750785	Jan 30, 2035	in 8 yr 9 mo	Product