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Last Updated: August 11, 2020

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TRANEXAMIC ACID Drug Profile

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Which patents cover Tranexamic Acid, and when can generic versions of Tranexamic Acid launch?

Tranexamic Acid is a drug marketed by Acic Pharms, Akorn, Am Regent, Amneal Pharms Co, Apollo, Apotex, Aurobindo Pharma Ltd, Caplin, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Micro Labs, Mylan Institutional, Virtus Pharms, Xgen Pharms, Zydus Pharms, Exela Pharma Scs Llc, Actavis Labs Fl Inc, Ani Pharms Inc, Apotex Inc, and Mylan. and is included in twenty-three NDAs.

The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

US ANDA Litigation and Generic Entry Outlook for Tranexamic Acid

A generic version of TRANEXAMIC ACID was approved as tranexamic acid by AM REGENT on August 10th, 2011.

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Drug patent expirations by year for TRANEXAMIC ACID
Drug Prices for TRANEXAMIC ACID

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Recent Clinical Trials for TRANEXAMIC ACID

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SponsorPhase
University of California, DavisPhase 3
Pediatric Emergency Care Applied Research NetworkPhase 3
Alberta Cancer FoundationPhase 3

See all TRANEXAMIC ACID clinical trials

Pharmacology for TRANEXAMIC ACID
Drug ClassAntifibrinolytic Agent
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for TRANEXAMIC ACID
Paragraph IV (Patent) Challenges for TRANEXAMIC ACID
Tradename Dosage Ingredient NDA Submissiondate
LYSTEDA TABLET;ORAL tranexamic acid 022430 2011-05-24

US Patents and Regulatory Information for TRANEXAMIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acic Pharms TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 202436-001 Feb 11, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 205228-001 Jul 17, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Apollo TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 212676-001 Jul 17, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 206634-001 Jun 9, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 091596-001 Mar 2, 2012 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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