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Serving leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Merck
UBS
Healthtrust
Cipla
McKinsey
Baxter
US Department of Justice
Fuji

Generated: October 24, 2017

DrugPatentWatch Database Preview

Tranexamic acid - Generic Drug Details

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What are the generic drug sources for tranexamic acid and what is the scope of tranexamic acid freedom to operate?

Tranexamic acid
is the generic ingredient in three branded drugs marketed by Viva Hlthcare, Emcure Pharms Ltd, Zydus Pharms Usa Inc, Ferring Pharms As, Mylan, Akorn, Aurobindo Pharma Ltd, Acic Fine Chems, Gland Pharma Ltd, Amneal Pharms Co, Virtus Pharms, Amerigen Pharms Ltd, Mylan Institutional, X-gen Pharms Inc, Pharmacia And Upjohn, Luitpold, Apotex Inc, Actavis Labs Fl Inc, and Fresenius Kabi Usa, and is included in twenty-two 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 seven drug master file entries for tranexamic acid. Twenty-five suppliers are listed for this compound.

Summary for Generic Name: tranexamic acid

US Patents:8
Tradenames:3
Applicants:19
NDAs:22
Drug Master File Entries: see list7
Suppliers / Packagers: see list25
Bulk Api Vendors: see list123
Clinical Trials: see list4,924
Patent Applications: see list4,328
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tranexamic acid at DailyMed

Pharmacology for Ingredient: tranexamic acid

Drug ClassAntifibrinolytic Agent
Physiological EffectDecreased Fibrinolysis
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms As
LYSTEDA
tranexamic acid
TABLET;ORAL022430-001Nov 13, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Amerigen Pharms Ltd
TRANEXAMIC ACID
tranexamic acid
TABLET;ORAL203256-001Jul 25, 2016DISCNNoNo► Subscribe► Subscribe► Subscribe
Ferring Pharms As
LYSTEDA
tranexamic acid
TABLET;ORAL022430-001Nov 13, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Pharmacia And Upjohn
CYKLOKAPRON
tranexamic acid
TABLET;ORAL019280-001Dec 30, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Virtus Pharms
TRANEXAMIC ACID
tranexamic acid
INJECTABLE;INJECTION202755-001Feb 25, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Viva Hlthcare
TRANEXAMIC ACID
tranexamic acid
INJECTABLE;INJECTION206713-001Jun 27, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Ferring Pharms As
LYSTEDA
tranexamic acid
TABLET;ORAL022430-001Nov 13, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Akorn
TRANEXAMIC ACID
tranexamic acid
INJECTABLE;INJECTION206594-001Sep 28, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Ferring Pharms As
LYSTEDA
tranexamic acid
TABLET;ORAL022430-001Nov 13, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Ferring Pharms As
LYSTEDA
tranexamic acid
TABLET;ORAL022430-001Nov 13, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tranexamic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
CYKLOKAPRON
tranexamic acid
TABLET;ORAL019280-001Dec 30, 1986► Subscribe► Subscribe
Pharmacia And Upjohn
CYKLOKAPRON
tranexamic acid
INJECTABLE;INJECTION019281-001Dec 30, 1986► Subscribe► Subscribe
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International Patent Family for Ingredient: tranexamic acid

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006023001► Subscribe
Japan2008508275► Subscribe
Japan2014193878► Subscribe
World Intellectual Property Organization (WIPO)2006023000► Subscribe
Japan2011168596► Subscribe
Japan5000504► Subscribe
Japan2008508276► Subscribe
Japan5205053► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
US Department of Justice
McKinsey
Citi
Julphar
Novartis
Daiichi Sankyo
Deloitte
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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