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Last Updated: March 28, 2024

TRANEXAMIC ACID Drug Patent 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, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa. and is included in twenty-four NDAs.

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

DrugPatentWatch® 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
Applied Health Research CentrePhase 3
Michael CusimanoPhase 3
The Physicians' Services Incorporated 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
Anatomical Therapeutic Chemical (ATC) Classes for TRANEXAMIC ACID
Paragraph IV (Patent) Challenges for TRANEXAMIC ACID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LYSTEDA Tablets tranexamic acid 650 mg 022430 2 2011-05-24

US Patents and Regulatory Information for TRANEXAMIC ACID

TRANEXAMIC ACID is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting TRANEXAMIC ACID

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷  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
Acic Pharms TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 202436-001 Feb 11, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 205228-001 Jul 17, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa TRANEXAMIC ACID tranexamic acid TABLET;ORAL 205133-001 Sep 21, 2015 AB 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.