Viewing data from:

TRANEXAMIC ACID

ANDA

TRANEXAMIC ACID | A202093 | ACTAVIS LABORATORIES FL INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: LYSTEDA(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Ferring B.V. v. Watson Pharmaceuticals, Inc. et al 2:2012cv01935 1 patentANDA 202093tranexamic acid	NVD	2012-11-09	Terminated 2015-06-11	—
Ferring B.V. v. Watson Pharmaceuticals, Inc. Florida, et al 3:2011cv00853 1 patentANDA 202093tranexamic acid	NVD	2011-11-25	Terminated 2015-06-11	—

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

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

2 letters from Drugs@FDA

Date	Submission	Document
Dec 28, 2012	ORIG -1	View Letter (PDF)
May 24, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 650MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 27, 2012

No patent or exclusivity listings for this strength.