Orange Book product · Brand (NDA)

ANGIOMAX RTU

BIVALIRUDIN

Brand (NDA)NDA 211215RX MAIA PHARMS INC

Jul 25, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 25, 2019
7 yr ago
Today
Patent 11903993 expires
Listed method-of-use patent (U-3817) expiration.
May 20, 2039
in 13 yr 1 mo
Patent 11918622 expires
Listed method-of-use patent (U-3817) expiration.
May 20, 2039
in 13 yr 1 mo
Patent 11992514 expires
Listed drug product patent expiration.
May 20, 2039
in 13 yr 1 mo
Patent 12472224 expires
Listed drug product patent expiration.
May 20, 2039
in 13 yr 1 mo

Active ingredient

BIVALIRUDIN

Strength

250MG/50ML (5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 211215

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
11903993	May 20, 2039	in 13 yr 1 mo	U-3817
11918622	May 20, 2039	in 13 yr 1 mo	U-3817
11992514	May 20, 2039	in 13 yr 1 mo	Product
12472224	May 20, 2039	in 13 yr 1 mo	ProductU-3817