TRANEXAMIC ACID Drug Patent Profile
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Which patents cover Tranexamic Acid, and when can generic versions of Tranexamic Acid launch?
Tranexamic Acid is a drug marketed by Acic Pharms, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Gland Pharma Ltd, Nexus, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa. and is included in twenty-six NDAs.
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tranexamic Acid
A generic version of TRANEXAMIC ACID was approved as tranexamic acid by AM REGENT on August 10th, 2011.
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Summary for TRANEXAMIC ACID
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 26 |
| Finished Product Suppliers / Packagers: | 31 |
| Raw Ingredient (Bulk) Api Vendors: | 258 |
| Clinical Trials: | 574 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| Philip Spinella | Phase 3 |
| Biomedical Advanced Research and Development Authority | Phase 3 |
| Vanderbilt University Medical Center | Phase 2 |
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
TRANEXAMIC ACID is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting TRANEXAMIC ACID
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acic Pharms | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 202436-001 | Feb 11, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205228-001 | Jul 17, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 203256-001 | Jul 25, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 202755-001 | Feb 25, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 209860-001 | Jan 14, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 207239-001 | Feb 13, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Exela Pharma | TRANEXAMIC ACID | tranexamic acid | SOLUTION;INTRAVENOUS | 212020-001 | Apr 15, 2019 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
