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LYSTEDA Drug Profile
» See Plans and Pricing
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-six 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 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 206 |
| Clinical Trials: | 14 |
| Patent Applications: | 3,004 |
| 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 |
|---|---|
| University of Missouri-Columbia | Early Phase 1 |
| The Miriam Hospital | Phase 4 |
| Shannon K. Laughlin-Tommaso | Phase 4 |
Pharmacology for LYSTEDA
| Drug Class | Antifibrinolytic Agent |
| Physiological Effect | Decreased 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5000504 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006023000 | Start Trial |
| Japan | 2008508275 | Start Trial |
| Japan | 2011168596 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
