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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.

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:	29
Raw Ingredient (Bulk) Api Vendors:	216
Clinical Trials:	470
Patent Applications:	6,930
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
Pediatric Emergency Care Applied Research Network	Phase 3
University of California, Davis	Phase 3
Montefiore Medical Center	Phase 4

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

Anatomical Therapeutic Chemical (ATC) Classes for tranexamic acid

B02AA	Amino acids
B02A	ANTIFIBRINOLYTICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

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			Y
Mylan Pharms Inc	TRANEXAMIC ACID	tranexamic acid	TABLET;ORAL	205133-001	Sep 21, 2015		DISCN	No	No
Gland	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	207239-001	Feb 13, 2017	AP	RX	No	No
Xgen Pharms	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	201580-001	Jun 14, 2013	AP	RX	No	No
Amneal Pharms Co	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	208840-001	Feb 28, 2017	AP	RX	No	No
Caplin	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	212360-001	Jul 17, 2019	AP	RX	No	No

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
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986

International Patents for tranexamic acid

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006023000
Japan	2008508276
Japan	2014193878
World Intellectual Property Organization (WIPO)	2006023001
Japan	2011168596
Japan	5205053