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Last Updated: August 19, 2022

Bivalirudin - Generic Drug Details

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What are the generic drug sources for bivalirudin and what is the scope of patent protection?

Bivalirudin is the generic ingredient in four branded drugs marketed by Sandoz Inc, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hospira Inc, Meitheal, Mylan Institutional, Shuangcheng, 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. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for bivalirudin

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Recent Clinical Trials for bivalirudin

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University Magna GraeciaN/A
Johns Hopkins UniversityPhase 1
Yan'an University Affiliated HospitalN/A

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Generic filers with tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing250MG/VIALINJECTABLE;INTRAVENOUS
See Plans and PricingSee Plans and Pricing250MG/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
Meitheal BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 091602-001 Jul 16, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shuangcheng BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 210031-001 Oct 23, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hainan Poly Pharm BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 213078-001 May 28, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Institutional BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 202471-001 Jun 1, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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