Tranexamic Acid Patent Expiration

Tranexamic Acid is Used for treating cyclic heavy menstrual bleeding. It was first introduced by Pharmacia And Upjohn Co in its drug Cyklokapron on Dec 30, 1986. Other drugs containing Tranexamic Acid are Lysteda, Tranexamic Acid. 31 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.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lysteda US7947739 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US8022106 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US8273795 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US8487005 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US8791160 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US8809394 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US8957113 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner
Lysteda US9060939 Tranexamic acid formulations Mar 04, 2025

(Expired)

J Molner



Tranexamic Acid's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tranexamic Acid:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children Philip Spinella NA RECRUITING
(Sep 1, 2026)
PHASE3
HTO and Tranexamic Acid Study Western University, Canada NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial Ottawa Hospital Research Institute NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy Youssef Yammine NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Tranexamic Acid for Anaemia Trial London School of Hygiene and Tropical Medicine NA RECRUITING
(Aug 1, 2026)
PHASE3
Extended Oral Tranexamic Acid After Total Knee Arthroplasty Campbell Clinic NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE3
APEX-STROKE EAGLE Domain (EAGLE) Fudan University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE3
Protest Trial: TXA vs Saline Corewell Health West NA ENROLLING BY INVITATION
(Jul 1, 2026)
PHASE3
Effect of TXA on Reducing Bruising After Filler Injection University of Wisconsin, Madison NA RECRUITING
(Jul 1, 2026)
PHASE2
Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH) St. Olavs Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean The George Washington University Biostatistics Center NA COMPLETED
(Jun 1, 2026)
PHASE3
Nebulized Tranexamic Acid in Sinus Surgery Assiut University NA COMPLETED
(Jun 1, 2026)
PHASE3
Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy University of California, San Francisco NA RECRUITING
(Jun 1, 2026)
PHASE2
Nebulized Versus Intravenous Tranexamic Acid for Hemoptysis Assiut University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Tranexamic Acid to Reduce Blood Loss in Spine Surgery Columbia University NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial Hamilton Health Sciences Corporation NA RECRUITING
(May 1, 2026)
PHASE3
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery Kristen Ban NA RECRUITING
(May 1, 2026)
PHASE2
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial. Assistance Publique - Hôpitaux de Paris NA COMPLETED
(Apr 1, 2026)
PHASE3
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis Vanderbilt University Medical Center NA RECRUITING
(Apr 1, 2026)
PHASE1
Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery Ulrich Ronellenfitsch, MD NA RECRUITING
(Apr 1, 2026)
PHASE3
Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty University of Alabama at Birmingham NA RECRUITING
(Apr 1, 2026)
PHASE3
Tranexamic Acid in Adult Spinal Deformity Surgery Hospital for Special Surgery, New York NA RECRUITING
(Mar 1, 2026)
PHASE3


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 I 3 Pharmaceuticals Llc and was approved on Jan 26, 2026.

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