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Last Updated: March 28, 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 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
Michael CusimanoPhase 3
The Physicians' Services Incorporated FoundationPhase 3
Applied Health Research CentrePhase 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 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
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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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