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LYSTEDA

NDA

TRANEXAMIC ACID | N022430 | AMRING PHARMACEUTICALS INC

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

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AMRING PHARMACEUTICALS INC v. RUBICON RESEARCH PRIVATE LTD. 2:2023cv03494	D.N.J.	2023-06-28	Terminated 2023-12-27	—
Ferring B.V. v. Watson Pharmaceuticals, Inc. et al 2:2012cv01935 1 patentANDA 202093tranexamic acid	D. Nev.	2012-11-09	Terminated 2015-06-11	—
Ferring B.V. v. Watson Pharmaceuticals, Inc. Florida, et al 3:2011cv00853 1 patentANDA 202093tranexamic acid	D. Nev.	2011-11-25	Terminated 2015-06-11	—
Ferring B.V. v. Apotex, Inc. et al 3:2011cv00485 1 patentANDA 202286tranexamic acid	D. Nev.	2011-07-08	Terminated 2014-03-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-5578 · 6 docket documents Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Tranexamic Acid Tablets, USP 1300 mg, a new strength differing from the reference listed drug LYSTEDA (Tranexamic Acid) 650 mg tablets	Suitability	2026-05-14	Open	Appco Pharma LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

270 trials from ClinicalTrials.gov — 9 recruiting, 2 active, 162 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial NCT02261415	Phase 3	Active	Sunnybrook Health Sciences Centre	1,386	2014-11 → 2027-08
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery NCT03128866	Early Phase 1	Active	M.D. Anderson Cancer Center	80	2017-05-19 → 2026-05-31
Tranexamic Acid Infusion During Elective Spine Surgery NCT04312880	Phase 4	By Invitation	Albany Medical College	65	2018-12-01 → 2021-01-01
Tranexamic Acid to Reduce Blood Loss in Spine Surgery NCT02314988	Phase 2/3	Recruiting	Columbia University	252	2020-06-15 → 2027-07
Tranexamic Acid in Adult Spinal Deformity Surgery NCT03553186	Phase 3	Recruiting	Hospital for Special Surgery, New York	100	2018-07-11 → 2027-03
Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma NCT03582293	Phase 3	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	554	2018-06-19 → 2029-10-30
Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion NCT03063892	Phase 4	Recruiting	Gregory M Georgiadis MD	200	2017-08-30 → 2026-09-01
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery NCT03849443	Early Phase 1	Recruiting	Rush University Medical Center	604	2019-08-26 → 2027-01-01
TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA NCT04304625	Phase 3	Recruiting	University Hospital, Bordeaux	1,380	2020-08-07 → 2027-09
The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients NCT03552705	Phase 2	Recruiting	Stanford University	50	2019-08-01 → 2027-01-14

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.8854

per ea

Lowest NADAC/Unit

$0.8854

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69918030130TRANEXAMIC ACID 650 MG TABLET	$0.8854	EA	Generic	—	2026-06-17
50268077213TRANEXAMIC ACID 650 MG TABLET	$0.8854	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$10.60

Highest Price

$10.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69918-0301-30TRANEXAMIC ACID 650MG TAB	$10.60	FSS	Nordic Pharma Inc.	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

5 letters from Drugs@FDA

Date	Submission	Document
Dec 9, 2020	SUPPL -9	View Letter (PDF)
Oct 4, 2013	SUPPL -4	View Letter (PDF)
Aug 22, 2013	SUPPL -3	View Letter (PDF)
Apr 11, 2011	SUPPL -2	View Letter (PDF)
Nov 19, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 650MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 13, 2009

No patent or exclusivity listings for this strength.