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Last Updated: May 28, 2022

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. Twenty-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

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
Ascension Genesys HospitalPhase 2/Phase 3
University of Missouri-ColumbiaEarly Phase 1
The Miriam HospitalPhase 4

See all LYSTEDA clinical trials

Pharmacology for LYSTEDA
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Tranexamic acid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
Japan 5205053 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006023001 See Plans and Pricing
Japan 2008508276 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006023000 See Plans and Pricing
Japan 2014193878 TRANEXAMIC ACID FORMULATIONS See Plans and Pricing
Japan 2011168596 TRANEXAMIC ACID FORMULATION See Plans and Pricing
>Country >Patent Number >Title >Estimated 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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