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Last Updated: August 11, 2020

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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 Pharmacia And Upjohn, 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, Ferring Pharms Inc, Actavis Labs Fl Inc, Ani Pharms Inc, Apotex Inc, and Mylan, and is included in twenty-six 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. Twenty-seven suppliers are listed for this compound.

Drug Prices for tranexamic acid

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Recent Clinical Trials for tranexamic acid

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SponsorPhase
Pediatric Emergency Care Applied Research NetworkPhase 3
University of California, DavisPhase 3
Rambam Health Care CampusN/A

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
Fresenius Kabi Usa TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 091596-001 Mar 2, 2012 AP RX No No   Start Trial   Start Trial   Start Trial
Apotex TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 209860-001 Jan 14, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Ferring Pharms Inc LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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
Pharmacia And Upjohn CYKLOKAPRON tranexamic acid INJECTABLE;INJECTION 019281-001 Dec 30, 1986   Start Trial   Start Trial
Pharmacia And Upjohn CYKLOKAPRON tranexamic acid TABLET;ORAL 019280-001 Dec 30, 1986   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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