Orange Book product · Brand (NDA)

TIROSINT-SOL

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 206977RX IBSA

Dec 15, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 15, 2016
9 yr 8 mo ago
Today
Patent 10537538 expires
Listed drug product patent expiration.
Feb 28, 2037
in 10 yr 10 mo
Patent 11096913 expires
Listed drug product patent expiration.
Feb 28, 2037
in 10 yr 10 mo
Patent 11241382 expires
Listed method-of-use patent (U-3757) expiration.
Sep 17, 2039
in 13 yr 5 mo
Patent 11241382 expires
Listed method-of-use patent (U-3758) expiration.
Sep 17, 2039
in 13 yr 5 mo
Patent 12564565 expires
Listed drug product patent expiration.
Sep 26, 2044
in 18 yr 6 mo

Active ingredient

LEVOTHYROXINE SODIUM

Strength

13MCG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 206977

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
10537538	Feb 28, 2037	in 10 yr 10 mo	Product
11096913	Feb 28, 2037	in 10 yr 10 mo	Product
11241382	Sep 17, 2039	in 13 yr 5 mo	U-3757
11241382	Sep 17, 2039	in 13 yr 5 mo	U-3758
12564565	Sep 26, 2044	in 18 yr 6 mo	Product