Tranexamic acid - Generic Drug Details
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What are the generic sources for tranexamic acid and what is the scope of patent protection?
Tranexamic acid
is the generic ingredient in three branded drugs marketed by Pfizer, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Micro Labs, Milla Pharms, Mylan Institutional, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Nexus, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, Appco, Aurobindo Pharma Usa, Bionpharma, and Rubicon Research, and is included in thirty-four NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Tranexamic acid has eight patent family members in two countries.
There are eight drug master file entries for tranexamic acid. Thirty-nine suppliers are listed for this compound.
Summary for tranexamic acid
| International Patents: | 8 |
| US Patents: | 8 |
| Tradenames: | 3 |
| Applicants: | 29 |
| NDAs: | 34 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 39 |
| Raw Ingredient (Bulk) Api Vendors: | 213 |
| Clinical Trials: | 677 |
| Patent Applications: | 6,866 |
| Drug Prices: | Drug price trends for tranexamic acid |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tranexamic acid |
| What excipients (inactive ingredients) are in tranexamic acid? | tranexamic acid excipients list |
| DailyMed Link: | tranexamic acid at DailyMed |
Recent Clinical Trials for tranexamic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | PHASE3 |
| Mayo Clinic | PHASE4 |
| University of Pittsburgh | PHASE4 |
Pharmacology for tranexamic acid
| Drug Class | Antifibrinolytic Agent |
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for tranexamic acid
Anatomical Therapeutic Chemical (ATC) Classes for tranexamic acid
Paragraph IV (Patent) Challenges for TRANEXAMIC ACID
| 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 tranexamic acid
Expired US Patents for tranexamic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Pfizer | CYKLOKAPRON | tranexamic acid | INJECTABLE;INJECTION | 019281-001 | Dec 30, 1986 | ⤷ Get Started Free | ⤷ Get Started Free |
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Amring Pharms | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tranexamic acid
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2008508275 | ⤷ Get Started Free | |
| World Intellectual Property Organization (WIPO) | 2006023000 | ⤷ Get Started Free | |
| Japan | 5000504 | ⤷ Get Started Free | |
| Japan | 2011168596 | TRANEXAMIC ACID FORMULATION | ⤷ Get Started Free |
| Japan | 5205053 | ⤷ Get Started Free | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Tranexamic Acid
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