TRANEXAMIC ACID - Generic Drug Details

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

Tranexamic acid is the generic ingredient in three branded drugs marketed by Pfizer, Acic Pharms, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Gland Pharma Ltd, Nexus, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa, and is included in twenty-nine 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. Thirty-five suppliers are listed for this compound.

Summary for TRANEXAMIC ACID

International Patents:	8
US Patents:	8
Tradenames:	3
Applicants:	27
NDAs:	29
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	258
Clinical Trials:	574
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
Biomedical Advanced Research and Development Authority	Phase 3
Philip Spinella	Phase 3
Vanderbilt University Medical Center	Phase 2

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	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
Micro Labs	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206713-001	Jun 27, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Institutional	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	091657-001	Nov 3, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	208840-001	Feb 28, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986	⤷ Sign Up	⤷ Sign Up
>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	⤷ Sign Up
Japan	5205053		⤷ Sign Up
Japan	2008508275		⤷ Sign Up
Japan	2011168596	TRANEXAMIC ACID FORMULATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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