Tranexamic Acid Patent Expiration

Tranexamic Acid is Used for treating cyclic heavy menstrual bleeding. It was first introduced by Pfizer Inc in its drug Cyklokapron on Dec 30, 1986. Other drugs containing Tranexamic Acid are Lysteda, Tranexamic Acid. 29 different companies have introduced drugs containing Tranexamic Acid.


Tranexamic Acid Patents

Given below is the list of patents protecting Tranexamic Acid, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lysteda US7947739 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US8022106 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US8273795 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US8487005 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US8791160 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US8809394 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US8957113 Tranexamic acid formulations Mar 04, 2025 Amring Pharms
Lysteda US9060939 Tranexamic acid formulations Mar 04, 2025 Amring Pharms



Tranexamic Acid's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

Tranexamic Acid Generic API Manufacturers

Several generic applications have been filed for Tranexamic Acid. The first generic version for Tranexamic Acid was by American Regent Inc and was approved on Aug 10, 2011. And the latest generic version is by Fresenius Kabi Usa Llc and was approved on Aug 15, 2024.

Given below is the list of companies who have filed for Tranexamic Acid generic, along with the locations of their manufacturing plants worldwide.


1. ACIC PHARMS

Acic Pharmaceuticals Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Acic Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Feb 22, 2019





2. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet Prescription ORAL AB Dec 27, 2012





3. AM REGENT

American Regent Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Aug 10, 2011





4. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP Oct 16, 2023


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





5. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Feb 28, 2017





6. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet Prescription ORAL AB Jul 25, 2016





7. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet Discontinued ORAL N/A Jan 27, 2014
100MG/ML

injectable Prescription INJECTION AP Jan 14, 2020


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





8. AUROBINDO PHARMA USA

Aurobindo Pharma Usa Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet Prescription ORAL AB Sep 21, 2015


Manufacturing Plant Locations
New

Aurobindo Pharma Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Usa as present at those locations.

Country City Firm Name
United States
East Windsor Aurobindo Pharma USA Inc





9. AVET LIFESCIENCES

Avet Lifesciences Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Avet Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Aug 12, 2014





10. CAPLIN

Caplin Steriles Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Caplin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Jul 17, 2019


Manufacturing Plant Locations
New

Caplin's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Caplin as present at those locations.

Country City Firm Name
United States
Creve Coeur Caplin, Dr David
India
Gummidipoondi Caplin Steriles Limited





11. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Discontinued INJECTION N/A Feb 25, 2016





12. EPIC PHARMA LLC

Epic Pharma Llc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Discontinued INJECTION N/A Sep 28, 2017





13. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Jan 14, 2016


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





14. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Mar 2, 2012
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP Aug 15, 2024


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC





15. GLAND

Gland Pharma Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Feb 13, 2017


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Sriperumbudur Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Hyderabad Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.





16. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP Apr 16, 2024





17. HERITAGE

Heritage Pharmaceuticals Inc Dba Avet Pharmaceuticals Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Heritage.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Feb 11, 2014


Manufacturing Plant Locations
New

Heritage's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Heritage as present at those locations.

Country City Firm Name
United States
Sacramento Heritage Baking Company Inc.
Caldwell Heritage Country Store-Heritage Cooperative
Kenton Heritage Cooperative
Fort Scott Heritage Acres Farm
Upper Sandusky Heritage Cooperative
Chino Heritage #2
Lisbon Heritage Cooperative, Inc.
Woodsfield Heritage Cooperative
Cairo Heritage Cooperative
South Burlington Heritage Aviation
De Graff Heritage Cooperative Inc
Middlebury Heritage Acres
Waterford Heritage Cooperative
New Philadelphia Heritage Cooperative
Van Nuys Heritage Candy Company, Inc.
London Heritage Cooperative Inc.
Springfield Heritage Cooperative, Inc
Ada Heritage Cooperative Inc
West Mansfield Heritage Cooperative Inc.
Richwood Heritage Cooperative, Inc
Plain City Heritage Cooperative Inc.
Minneapolis Heritage Deli Provisions, LLC
London Heritage Cooperative, Inc
Dola Heritage Cooperative Inc
Canfield Heritage Cooperative
Alger Heritage Cooperative
Beloit Heritage Cooperative
Mc Cutchenville Heritage Cooperative, Inc
Vanlue Heritage Cooperative
Fletcher Heritage Cooperative Inc
West Liberty Heritage Cooperative, Inc
Urbana Heritage Cooperative Inc
Morgantown Heritage Animal Hospital





18. MICRO LABS

Micro Labs Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Jun 27, 2017


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Bangalore Micro Labs Limited
Verna Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory





19. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Nov 3, 2011


Manufacturing Plant Locations
New

Mylan Institutional's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





20. NEXUS

Nexus Pharmaceuticals Llc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Nexus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/100ML (10MG/ML)

solution Prescription INTRAVENOUS AP Apr 16, 2024


Manufacturing Plant Locations
New

Nexus's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Nexus as present at those locations.

Country City Firm Name
United States
Adams Nexus Cooperative
San Diego Nexus Dx, Inc
Brownsdale Nexus Cooperative
Cottonwood Heights Nexus CMF, LLC
Salt Lake City Nexus Spine, LLC
Bedford Park Nexus Distribution Corporation
Le Roy Nexus Cooperative
Lansing Nexus Cooperative
Alden Nexus Cooperative
Lenexa Nexus Medical LLC
Rose Creek Nexus Cooperative
Emmons Nexus Cooperative
Conger Nexus Cooperative
Cerritos Nexus Foods Inc
Pleasant Prairie Nexus Pharmaceuticals Inc
Lincolnshire Nexus Pharmaceuticals, LLC
Bedford Park Nexus Distribution Corp.
Santa Fe Springs Nexus Foods, Inc.





21. PROVEPHARM SAS

Provepharm Sas has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Provepharm Sas.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Jul 17, 2019


Manufacturing Plant Locations
New

Provepharm Sas's manufacturing plants are situated in 1 country - France. Given below are the details of these plant locations as well as the firm names of Provepharm Sas as present at those locations.

Country City Firm Name
France
Marseille Provepharm Sas





22. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Discontinued INJECTION N/A Jun 9, 2016


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





23. RUBICON

Rubicon Research Private Ltd has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
650MG

tablet Prescription ORAL AB Jun 11, 2024


Manufacturing Plant Locations
New

Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.

Country City Firm Name
United States
Geismar Rubicon, LLC
Indianapolis Rubicon Foods LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





24. XGEN PHARMS

Xgen Pharmaceuticals Djb Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Xgen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Prescription INJECTION AP Jun 14, 2013





25. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Tranexamic Acid. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML

injectable Discontinued INJECTION N/A Jul 17, 2017