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Last Updated: July 12, 2020

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LYSTEDA Drug Profile


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

Lysteda is a drug marketed by Ferring Pharms Inc 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. Twenty-six suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

US ANDA Litigation and Generic Entry Outlook for Lysteda

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

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Drug patent expirations by year for LYSTEDA
Drug Prices for LYSTEDA

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Recent Clinical Trials for LYSTEDA

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4
Shannon K. Laughlin-TommasoPhase 4
Universidad Autonoma de Nuevo LeonPhase 2

See all LYSTEDA clinical trials

Pharmacology for LYSTEDA
Drug ClassAntifibrinolytic Agent
Physiological EffectDecreased Fibrinolysis
Paragraph IV (Patent) Challenges for LYSTEDA
Tradename Dosage Ingredient NDA Submissiondate
LYSTEDA TABLET;ORAL tranexamic acid 022430 2011-05-24

US Patents and Regulatory Information for LYSTEDA

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Harvard Business School
McKinsey
Express Scripts
Mallinckrodt

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