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Tranexamic acid - Generic Drug Details
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What are the generic drug sources for tranexamic acid and what is the scope of patent protection?
Tranexamic acid
is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Acic Pharms, Akorn, Am Regent, Amneal Pharms Co, Apollo, Apotex, Aurobindo Pharma Ltd, Caplin, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Micro Labs, Mylan Institutional, Virtus Pharms, Xgen Pharms, Zydus Pharms, Exela Pharma, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms Inc, Apotex Inc, and Mylan Pharms Inc, and is included in twenty-six 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. Twenty-six suppliers are listed for this compound.
Summary for tranexamic acid
| International Patents: | 8 |
| US Patents: | 8 |
| Tradenames: | 3 |
| Applicants: | 23 |
| NDAs: | 26 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 26 |
| Bulk Api Vendors: | 203 |
| Clinical Trials: | 446 |
| Patent Applications: | 6,539 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Pediatric Emergency Care Applied Research Network | Phase 3 |
| University of California, Davis | Phase 3 |
| Michael Smith Foundation for Health Research | Phase 1/Phase 2 |
Pharmacology for tranexamic acid
| Drug Class | Antifibrinolytic Agent |
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for tranexamic acid
Paragraph IV (Patent) Challenges for TRANEXAMIC ACID
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LYSTEDA | TABLET;ORAL | tranexamic acid | 022430 | 2011-05-24 |
US Patents and Regulatory Information for tranexamic acid
| 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 | Y | Start Trial | ||
| Gland Pharma Ltd | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 207239-001 | Feb 13, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Xgen Pharms | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 201580-001 | Jun 14, 2013 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for tranexamic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CYKLOKAPRON | tranexamic acid | INJECTABLE;INJECTION | 019281-001 | Dec 30, 1986 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CYKLOKAPRON | tranexamic acid | TABLET;ORAL | 019280-001 | Dec 30, 1986 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tranexamic acid
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2008508275 | Start Trial |
| Japan | 2014193878 | Start Trial |
| Japan | 5000504 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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