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Tranexamic acid - Generic Drug Details

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Tranexamic acid is the generic ingredient in three branded drugs marketed by Emcure Pharms Ltd, Ferring Pharms As, Mylan, Akorn, Aurobindo Pharma Ltd, Acic Fine Chems, Gland Pharma Ltd, North Creek 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 eighteen NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eight patent family members in two countries.

There are seven drug master file entries for tranexamic acid. Eighteen suppliers are listed for this compound.

Summary for Generic Name: tranexamic acid

Tradenames:3
Patents:8
Applicants:16
NDAs:18
Drug Master File Entries: see list7
Suppliers / Packagers: see list18
Bulk Api Vendors: see list123
Clinical Trials: see list2,072
Patent Applications: see list3,033
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amerigen Pharms Ltd
TRANEXAMIC ACID
tranexamic acid
TABLET;ORAL203256-001Jul 25, 2016DISCNNoNo► subscribe► subscribe
Acic Fine Chems
TRANEXAMIC ACID
tranexamic acid
INJECTABLE;INJECTION202436-001Feb 11, 2014RXNoNo► subscribe► subscribe
Pharmacia And Upjohn
CYKLOKAPRON
tranexamic acid
INJECTABLE;INJECTION019281-001Dec 30, 1986RXYesYes► subscribe► 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, 19863,950,405► subscribe
Pharmacia And Upjohn
CYKLOKAPRON
tranexamic acid
INJECTABLE;INJECTION019281-001Dec 30, 19863,950,405► subscribe
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International Patent Family for Ingredient: tranexamic acid

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006023000► subscribe
Japan5000504► subscribe
Japan2011168596► 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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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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