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Last Updated: May 25, 2024

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-three 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 10th, 2011.

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Drug patent expirations by year for LYSTEDA
Drug Prices for LYSTEDA

See drug prices for LYSTEDA

Recent Clinical Trials for LYSTEDA

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

SponsorPhase
LuxurgeryPhase 4
Ascension Genesys HospitalPhase 2/Phase 3
University of Missouri-ColumbiaEarly Phase 1

See all LYSTEDA clinical trials

Pharmacology for LYSTEDA
Drug ClassAntifibrinolytic Agent
Physiological EffectDecreased Fibrinolysis
Anatomical Therapeutic Chemical (ATC) Classes for LYSTEDA
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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

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

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

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

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

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

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
>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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