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Last Updated: September 28, 2021

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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 Pfizer, Acic Pharms, Akorn, Am Regent, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Caplin, Emcure Pharms Ltd, 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

See drug prices for tranexamic acid

Recent Clinical Trials for tranexamic acid

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

SponsorPhase
Pediatric Emergency Care Applied Research NetworkPhase 3
University of California, DavisPhase 3
Montefiore Medical CenterPhase 4

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 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Mylan Pharms Inc TRANEXAMIC ACID tranexamic acid TABLET;ORAL 205133-001 Sep 21, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gland TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 207239-001 Feb 13, 2017 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Xgen Pharms TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 201580-001 Jun 14, 2013 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal Pharms Co TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 208840-001 Feb 28, 2017 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Caplin TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 212360-001 Jul 17, 2019 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pharmacia And Upjohn CYKLOKAPRON tranexamic acid TABLET;ORAL 019280-001 Dec 30, 1986 ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 ⤷  Free Forever Trial
Japan 2008508276 ⤷  Free Forever Trial
Japan 2014193878 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2006023001 ⤷  Free Forever Trial
Japan 2011168596 ⤷  Free Forever Trial
Japan 5205053 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Express Scripts
Baxter
Colorcon
Medtronic

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