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Last Updated: March 28, 2024

BIVALIRUDIN - Generic Drug Details


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What are the generic drug sources for bivalirudin and what is the scope of freedom to operate?

Bivalirudin is the generic ingredient in four branded drugs marketed by Sandoz, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, Maia Pharms Inc, and Baxter Hlthcare Corp, and is included in fourteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for bivalirudin. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for BIVALIRUDIN

See drug prices for BIVALIRUDIN

Recent Clinical Trials for BIVALIRUDIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Veralox TherapeuticsPhase 2
University Magna GraeciaN/A
Johns Hopkins UniversityPhase 1

See all BIVALIRUDIN clinical trials

Generic filers with tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial250MG/VIALINJECTABLE;INTRAVENOUS
⤷  Try a Trial⤷  Try a Trial250MG/VIALINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BIVALIRUDIN
Paragraph IV (Patent) Challenges for BIVALIRUDIN
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 BIVALIRUDIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eugia Pharma BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 205962-001 Jul 27, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551-001 Nov 22, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Dr Reddys BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 201577-001 May 26, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090811-001 Jul 14, 2015 AP RX No No ⤷  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 BIVALIRUDIN

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

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