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.
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: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 230 |
| Clinical Trials: | 23 |
| 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 |
|---|---|
| Ascension Genesys Hospital | Phase 2/Phase 3 |
| University of Missouri-Columbia | Early Phase 1 |
| The Miriam Hospital | Phase 4 |
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: 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
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 |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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