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Generated: February 19, 2018

DrugPatentWatch Database Preview

Bivalirudin - Generic Drug Details

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

Bivalirudin
is the generic ingredient in three branded drugs marketed by The Medicines Co, Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, and Baxter Hlthcare Corp, and is included in eight 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 thirteen drug master file entries for bivalirudin. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.
Pharmacology for bivalirudin
Tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up250MG/VIALINJECTABLE;INTRAVENOUS
➤ Sign Up➤ Sign Up250MGINJECTABLE;INJECTION
➤ Sign Up➤ Sign Up250MGINJECTABLE;INJECTION

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
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816-001 Jul 14, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;IV (INFUSION) 208374-001 Dec 21, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551-001 Nov 22, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;IV (INFUSION) 208374-002 Dec 21, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
The Medicines Co ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090811-001 Jul 14, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 204876-001 Jul 6, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 201577-001 May 26, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090189-001 Oct 28, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
The Medicines Co ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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