Tranexamic acid - Generic Drug Details

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What are the generic drug 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, Anda Repository, Apotex, Caplin, Emcure Pharms Ltd, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, 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.

Summary for tranexamic acid

International Patents:	8
US Patents:	8
Tradenames:	3
Applicants:	24
NDAs:	26
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	240
Clinical Trials:	526
Patent Applications:	7,130
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for tranexamic acid
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tranexamic acid
What excipients (inactive ingredients) are in tranexamic acid?	tranexamic acid excipients list
DailyMed Link:	tranexamic acid at DailyMed

See drug prices for tranexamic acid

Recent Clinical Trials for tranexamic acid

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

Sponsor	Phase
UNITAID	Phase 3
Asociacion Instituto Biodonostia	Phase 4
Acibadem University	N/A

See all tranexamic acid clinical trials

Pharmacology for tranexamic acid

Drug Class	Antifibrinolytic Agent
Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for tranexamic acid

Antifibrinolytic Agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	205035-001	Jan 14, 2016	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Micro Labs	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206713-001	Jun 27, 2017	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Gland	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	207239-001	Feb 13, 2017	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Akorn	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206594-001	Sep 28, 2017		DISCN	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

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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

International Patents for tranexamic acid

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Country	Patent Number	Title	Estimated Expiration
Japan	2014193878	TRANEXAMIC ACID FORMULATIONS	See Plans and Pricing
Japan	2011168596	TRANEXAMIC ACID FORMULATION	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2006023001		See Plans and Pricing
Japan	5205053		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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