Orange Book product · Brand (NDA)

ANGIOMAX

BIVALIRUDIN

Brand (NDA)NDA 020873TE APRX SANDOZ

Dec 15, 2000

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 15, 2000
25 yr 11 mo ago
Today
Patent 7582727 expires
Listed drug product patent expiration.
Jul 27, 2028
in 2 yr 2 mo
Patent 7598343 expires
Listed drug product patent expiration.
Jul 27, 2028
in 2 yr 2 mo
Patent 7582727*PED expires
Listed listed patent expiration.
Jan 27, 2029
in 2 yr 8 mo
Patent 7598343*PED expires
Listed listed patent expiration.
Jan 27, 2029
in 2 yr 8 mo

Active ingredient

BIVALIRUDIN

Strength

250MG/VIAL

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 020873

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
7582727	Jul 27, 2028	in 2 yr 2 mo	Product
7598343	Jul 27, 2028	in 2 yr 2 mo	Product
7582727*PED	Jan 27, 2029	in 2 yr 8 mo
7598343*PED	Jan 27, 2029	in 2 yr 8 mo