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Last Updated: September 27, 2022

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, 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 Aurobindo Pharma Usa, 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-eight 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
Franciscus GasthuisPhase 3
Asociacion Instituto BiodonostiaPhase 4
Acibadem UniversityN/A

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Pharmacology for tranexamic acid
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 Strength NDA ANDAs Submitted Submissiondate
LYSTEDA Tablets tranexamic acid 650 mg 022430 2 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acic Pharms TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 202436-001 Feb 11, 2014 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pharmacia And Upjohn CYKLOKAPRON tranexamic acid TABLET;ORAL 019280-001 Dec 30, 1986 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.