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Last Updated: July 2, 2020

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ANGIOMAX Drug Profile


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When do Angiomax patents expire, and when can generic versions of Angiomax launch?

Angiomax is a drug marketed by Sandoz Inc and Maia Pharms Inc and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ANGIOMAX is bivalirudin. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

US ANDA Litigation and Generic Entry Outlook for Angiomax

A generic version of ANGIOMAX was approved as bivalirudin by HOSPIRA INC on July 14th, 2015.

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Drug patent expirations by year for ANGIOMAX
Drug Prices for ANGIOMAX

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Recent Clinical Trials for ANGIOMAX

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SponsorPhase
Pacific UniversityPhase 4
Legacy Health SystemPhase 4
Qian GongPhase 2

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Pharmacology for ANGIOMAX
Paragraph IV (Patent) Challenges for ANGIOMAX
Tradename Dosage Ingredient NDA Submissiondate
ANGIOMAX INJECTABLE;INTRAVENOUS bivalirudin 020873 2009-09-01

US Patents and Regulatory Information for ANGIOMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sandoz Inc ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Maia Pharms Inc ANGIOMAX RTU bivalirudin SOLUTION;INTRAVENOUS 211215-001 Jul 25, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ANGIOMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0489070 C00489070/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0489070 SPC/GB04/035 United Kingdom   Start Trial PRODUCT NAME: H-(D-PHE)-PRO-ARG-PRO-(GLY)4-ASN-GLY-ASP-PHE-GLU-GLU-ILE-PRO-GLU-GLU-TYR-LEU-OH, OPTIONALLY IN THE FORM OF ITS PHARMACEUTICALLY ACCEPTABLE SALT (BIVALIRUDIN); REGISTERED: UK EU/1/04/289/001 20040920
0489070 CA 2004 00032 Denmark   Start Trial
0489070 300162 Netherlands   Start Trial PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Moodys
McKesson
Harvard Business School
Mallinckrodt

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