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 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.
Summary for LYSTEDA
International Patents: | 8 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 251 |
Clinical Trials: | 24 |
Formulation / Manufacturing: | see details |
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 |


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 |
Pharmacology for LYSTEDA
Drug Class | Antifibrinolytic Agent |
Physiological Effect | Decreased 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Tranexamic acid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 | 2011168596 | TRANEXAMIC ACID FORMULATION | ⤷ Try a Trial |
Japan | 2008508276 | ⤷ Try a Trial | |
Japan | 5000504 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2006023001 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |