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Dow
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Baxter
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Colorcon

Last Updated: August 15, 2020

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Direct Thrombin Inhibitor Drug Class List

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Drugs in Drug Class: Direct Thrombin Inhibitor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374-001 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374-002 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090189-001 Oct 28, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551-001 Nov 22, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Shuangcheng BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 210031-001 Oct 23, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816-001 Jul 14, 2015 AP RX No No   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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Colorcon
Express Scripts
Dow
Medtronic

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