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Last Updated: September 22, 2023

ANGIOMAX Drug Patent 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 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. Fourteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Angiomax

A generic version of ANGIOMAX was approved as bivalirudin by HOSPIRA 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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Legacy Health SystemPhase 4
Pacific UniversityPhase 4
Qian GongPhase 2

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Pharmacology for ANGIOMAX
Paragraph IV (Patent) Challenges for ANGIOMAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ANGIOMAX For Injection bivalirudin 250 mg/vial 020873 1 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 ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sandoz ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Maia Pharms Inc ANGIOMAX RTU bivalirudin SOLUTION;INTRAVENOUS 211215-001 Jul 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ANGIOMAX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
The Medicines Company UK Ltd Angiox bivalirudin EMEA/H/C/000562
Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel.
Withdrawn no no no 2004-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for ANGIOMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0489070 22/2004 Austria ⤷  Try a Trial PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920
0489070 91119 Luxembourg ⤷  Try a Trial 91119, EXPIRES: 20150817
0489070 300162 Netherlands ⤷  Try a Trial PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
0489070 CA 2004 00032 Denmark ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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