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Last Updated: December 7, 2021

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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, Akorn, Am Regent, Amneal Pharms Co, Apotex, Caplin, Emcure Pharms Ltd, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Virtus Pharms, Xgen Pharms, Zydus Pharms, Exela Pharma, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, Apotex Inc, and Mylan Pharms Inc, 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-nine 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
University of California, DavisPhase 3
Daniel Nishijima, MD, MASPhase 3
Pediatric Emergency Care Applied Research NetworkPhase 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 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
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Exela Pharma TRANEXAMIC ACID tranexamic acid SOLUTION;INTRAVENOUS 212020-001 Apr 15, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fresenius Kabi Usa TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 091596-001 Mar 2, 2012 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Caplin TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 212360-001 Jul 17, 2019 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Emcure Pharms Ltd TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 203521-001 Aug 12, 2014 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal Pharms Co TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 208840-001 Feb 28, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer CYKLOKAPRON tranexamic acid INJECTABLE;INJECTION 019281-001 Dec 30, 1986 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Pharmacia And Upjohn CYKLOKAPRON tranexamic acid TABLET;ORAL 019280-001 Dec 30, 1986 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRANEXAMIC ACID

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2006023000 ⤷  Try it Free
Japan 2008508275 ⤷  Try it Free
Japan 5000504 ⤷  Try it Free
World Intellectual Property Organization (WIPO) 2006023001 ⤷  Try it Free
Japan 2011168596 ⤷  Try it Free
Japan 5205053 ⤷  Try it Free
Japan 2008508276 ⤷  Try it Free
>Country >Patent Number >Estimated Expiration

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