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Generated: August 18, 2017
What are the generic drug sources for tranexamic acid and what is the scope of tranexamic acid freedom to operate?
Tranexamic acid is the generic ingredient in three branded drugs marketed by Micro Labs, Emcure Pharms Ltd, Ferring Pharms As, Mylan, Akorn, Aurobindo Pharma Ltd, Acic Fine Chems, Gland Pharma Ltd, Amneal Pharms Co, North Creek Pharms, Amerigen Pharms Ltd, Mylan Institutional, X-gen Pharms Inc, Pharmacia And Upjohn, Luitpold, Apotex Inc, Actavis Labs Fl Inc, and Fresenius Kabi Usa, and is included in twenty NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 8 |
| Applicants: | 18 |
| NDAs: | 20 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 22 |
| Bulk Api Vendors: see list | 123 |
| Clinical Trials: see list | 4,857 |
| Patent Applications: see list | 4,518 |
| Therapeutic Class: | Blood Products/Modifiers/ Volume Expanders |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | tranexamic acid at DailyMed |
| Drug Class | Antifibrinolytic Agent |
| Physiological Effect | Decreased Fibrinolysis |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Emcure Pharms Ltd | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 203521-001 | Aug 12, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Mylan | TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 205133-001 | Sep 21, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Actavis Labs Fl Inc | TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 202093-001 | Dec 27, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Ferring Pharms As | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Luitpold | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 201885-001 | Aug 10, 2011 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharmacia And Upjohn | CYKLOKAPRON | tranexamic acid | TABLET;ORAL | 019280-001 | Dec 30, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Pharmacia And Upjohn | CYKLOKAPRON | tranexamic acid | INJECTABLE;INJECTION | 019281-001 | Dec 30, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2008508276 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2014193878 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5000504 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2006023000 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5205053 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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