Orange Book product · Brand (NDA)

SAMSCA

TOLVAPTAN

Brand (NDA)NDA 022275TE AB1RX OTSUKA

May 19, 2009

Approved

Brand (NDA)

Application

AB1

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 19, 2009
17 yr 4 mo ago
Today
Patent 8501730 expires
Listed drug substance patent expiration.
Sep 01, 2026
in 2 mo
Patent 10905694 expires
Listed drug product patent expiration.
Apr 07, 2030
in 3 yr 10 mo

Active ingredient

TOLVAPTAN

Strength

15MG

Dosage form

TABLET

Route

ORAL

TE code

AB1

Application

NDA 022275

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
8501730	Sep 01, 2026	in 2 mo	Substance
10905694	Apr 07, 2030	in 3 yr 10 mo	Product