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CYKLOKAPRON

NDA

TRANEXAMIC ACID | N019280 | PHARMACIA AND UPJOHN CO

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov — 5 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy NCT07672158	Phase 3	Not Yet Recruiting	Murdoch Childrens Research Institute	52	2026-07 → 2029-04
Endoscopic Application of Hemostatic Drug Powder in Lower Gastrointestinal Bleeding: A Pilot Study NCT07679139	N/A	Not Yet Recruiting	National Cheng-Kung University Hospital	60	2026-07-01 → 2027-12-31
Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial NCT06648369	N/A	Recruiting	Insel Gruppe AG, University Hospital Bern	50	2025-08-07 → 2028-11-30
Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery NCT07362992	Early Phase 1	Recruiting	Wolfson Medical Center	112	2026-07-01 → 2028-12-31
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery NCT07581457	N/A	Recruiting	Poznan University of Medical Sciences	90	2026-06-01 → 2027-06-30
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean NCT03364491	Phase 3	Completed	The George Washington University Biostatistics Center	11,000	2018-03-15 → 2021-10-29
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery NCT04244981	Phase 4	Terminated	SHI Jia	476	2023-10-25 → 2025-04-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Tranexamic Acid* (2023)

Total Spending

$2.9M

Total Claims

32,829

Beneficiaries

19,495

Avg Cost/Unit

$2.38

Spending Trend

$1.8M(2019)→$2.1M(2020)→$2.3M(2021)→$2.6M(2022)→$2.9M(2023)

YoY Change:-11.6%

5yr CAGR:-5.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

HUNAN DONGTING PHARMACEUTICAL CO LTDTRANEXAMIC ACID

DMF 141811999

ALP PHARM BEIJING CO LTDTRANEXAMIC ACID

DMF 222772008

ASAHI KASEI FINECHEM CO LTDTRANEXAMIC ACID USP

DMF 253312011

KYOWA PHARMA CHEMICAL CO LTDTRANEXAMIC ACID DRUG SUBSTANCE

DMF 261282012

SHILPA PHARMA LIFESCIENCES LTDTRANEXAMIC ACID USP

DMF 330862018

AMI LIFESCIENCES PRIVATE LTDTRANEXAMIC ACID USP

DMF 363362021

MALLADI DRUGS AND PHARMACEUTICALS LTDTRANEXAMIC ACID

DMF 371302022

KP MANISH GLOBAL INGREDIENTS PVT LTDTRANEXAMIC ACID USP

DMF 398252024

ZHEJIANG BAMBOO PHARMACEUTICALS CO LTDTRANEXAMIC ACID

DMF 414072025

DAIICHI SANKYO CO LTDInactiveTRANEXAMIC ACID

DMF 38641980

PHARMACIA AND UPJOHNInactiveTRANEXAMIC ACID

DMF 48561983

CMIC CMO CO LTDInactiveTRANEXAMIC ACID

DMF 94181991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 9, 1999	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 1986

No patent or exclusivity listings for this strength.