LYSTEDA Drug Patent Profile

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When do Lysteda patents expire, and when can generic versions of Lysteda launch?

Lysteda is a drug marketed by Amring Pharms and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in two countries.

The generic ingredient in LYSTEDA is tranexamic acid. There are eight drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lysteda

A generic version of LYSTEDA was approved as tranexamic acid by AM REGENT on August 10^th, 2011.

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Summary for LYSTEDA

International Patents:	8
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	258
Clinical Trials:	24
Patent Applications:	3,099
Drug Prices:	Drug price information for LYSTEDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYSTEDA
What excipients (inactive ingredients) are in LYSTEDA?	LYSTEDA excipients list
DailyMed Link:	LYSTEDA at DailyMed

Drug patent expirations by year for LYSTEDA

Recent Clinical Trials for LYSTEDA

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

Sponsor	Phase
Luxurgery	Phase 4
Ascension Genesys Hospital	Phase 2/Phase 3
University of Missouri-Columbia	Early Phase 1

See all LYSTEDA clinical trials

Pharmacology for LYSTEDA

Drug Class	Antifibrinolytic Agent
Physiological Effect	Decreased Fibrinolysis

Paragraph IV (Patent) Challenges for LYSTEDA

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 LYSTEDA

LYSTEDA is protected by eight US patents.

Patents protecting LYSTEDA

Tranexamic acid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Tranexamic acid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
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Patent Expiration: ⤷ Sign Up

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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
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for LYSTEDA

See the table below for patents covering LYSTEDA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	5205053		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006023001		⤷ Sign Up
Japan	2008508276		⤷ Sign Up
Japan	2011168596	TRANEXAMIC ACID FORMULATION	⤷ Sign Up
Japan	2014193878	TRANEXAMIC ACID FORMULATIONS	⤷ Sign Up
Japan	2008508275		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration