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Last Updated: March 29, 2024

Tranexamic acid - Generic Drug Details


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What are the generic sources for tranexamic acid and what is the scope of patent protection?

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, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa, and is included in twenty-seven 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-four suppliers are listed for this compound.

Drug Prices for tranexamic acid

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Recent Clinical Trials for tranexamic acid

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

SponsorPhase
The Physicians' Services Incorporated FoundationPhase 3
Applied Health Research CentrePhase 3
Michael CusimanoPhase 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 206713-001 Jun 27, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex TRANEXAMIC ACID tranexamic acid TABLET;ORAL 202286-001 Jan 27, 2014 DISCN 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tranexamic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CYKLOKAPRON tranexamic acid INJECTABLE;INJECTION 019281-001 Dec 30, 1986 ⤷  Try a Trial ⤷  Try a Trial
Pharmacia And Upjohn CYKLOKAPRON tranexamic acid TABLET;ORAL 019280-001 Dec 30, 1986 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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