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Last Updated: July 19, 2024

TRANEXAMIC ACID - Generic Drug Details

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What are the generic drug sources for tranexamic acid and what is the scope of freedom to operate?

Tranexamic acid is the generic ingredient in three branded drugs marketed by Pfizer, 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, Gland Pharma Ltd, Nexus, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa, and is included in twenty-nine NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tranexamic acid has eight patent family members in two countries.

There are eight drug master file entries for tranexamic acid. Thirty-five suppliers are listed for this compound.


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Recent Clinical Trials for TRANEXAMIC ACID

Identify potential brand extensions & 505(b)(2) entrants

Philip SpinellaPhase 3
Biomedical Advanced Research and Development AuthorityPhase 3
Vanderbilt University Medical CenterPhase 2

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Co TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 208840-001 Feb 28, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd TRANEXAMIC ACID tranexamic acid SOLUTION;INTRAVENOUS 218599-001 Apr 16, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Exela Pharma TRANEXAMIC ACID tranexamic acid SOLUTION;INTRAVENOUS 212020-001 Apr 15, 2019 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nexus TRANEXAMIC ACID tranexamic acid SOLUTION;INTRAVENOUS 216877-001 Apr 16, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 091657-001 Nov 3, 2011 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avet Lifesciences TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 203521-001 Aug 12, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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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