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AMICAR

NDA

AMINOCAPROIC ACID | N015197 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara FDA-2018-P-0097 · 4 docket documents The law firm Hyman, Phelps & McNamara filed this citizen petition requesting that FDA amend the Orange Book to designate Amicar (aminocaproic acid) Tablets, 500 mg, approved under NDA 015197, as a Reference Standard to facilitate ANDA submissions for generic versions of the drug product, noting that	Other	2018-01-08	Withdrawn	Hyman, Phelps & McNamara
Citizen Petition from Hyman, Phelps & McNamara PC FDA-2017-P-5435 · 3 docket documents Hyman, Phelps & McNamara PC filed this citizen petition requesting that the FDA designate Amicar (aminocaproic acid) Tablets, 500 mg, approved under NDA 015197, as a Reference Standard in the Orange Book to enable submission of an ANDA for a generic version. The petitioner argues that because the cu	Other	2017-09-06	Withdrawn	Hyman, Phelps & McNamara PC
Citizen Petition from Menn Law Firm LTD FDA-2017-P-2131 · 3 docket documents Menn Law Firm LTD, on behalf of a client, filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate AMICAR (Aminocaproic acid) 500mg Tablets as the Reference Standard for ANDA purposes, since the previously designated AMICAR 1g Tab	505(q)	2017-04-05	Withdrawn	Menn Law Firm LTD

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

Clinical Trials

20 trials from ClinicalTrials.gov, 1 active, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Amicar for Children Having Craniofacial Surgery NCT02229968	Phase 2	Active	Children's National Research Institute	22	2014-10 → 2028-03
Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery NCT01248104	N/A	Completed	Loma Linda University	100	2010-03 → 2015-02
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.NCT03365999	Phase 2	Completed	Universidad Autonoma de Nuevo Leon	92	2017-10-15 → 2019-07-01
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement NCT04187014	Phase 2	Completed	Carlos A Acosta-Olivo	90	2020-02-06 → 2021-04-26
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery NCT00320619	N/A	Completed	National Heart, Lung, and Blood Institute (NHLBI)	182	2000-09 → 2006-02
TXA vs. Amicar in Total Knee and Hip Arthroplasty NCT02030821	Phase 4	Completed	Duke University	246	2015-01 → 2017-11-12
Amicar Pharmacokinetics of Children Having Craniofacial Surgery NCT00912119	Phase 1	Completed	Paul Stricker	18	2009-05 → 2011-10
Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement NCT01873768	Phase 4	Completed	Miller Orthopedic Specialists	194	2014-01 → 2015-12
Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation NCT01398280	Early Phase 1	Completed	University of California, San Diego	15	2011-07 → 2012-12
Bradykinin Receptor Antagonism During Cardiopulmonary Bypass NCT00223704	Phase 2/3	Completed	Vanderbilt University	150	2006-05 → 2012-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$109.97

Highest Price

$171.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-1110-13AMINOCAPROIC ACID 1000MG TAB	$171.30	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
00054-1110-13AMINOCAPROIC ACID 1000MG TAB	$109.97	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026

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

API Supply Chain9 active DMFs

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

SUNNY PHARMTECH INCAMINOCAPROIC ACID, USP

DMF 304392016

DIPHARMA FRANCIS SRLAMINOCAPROIC ACID

DMF 311322016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDAMINOCAPROIC ACID

DMF 314782017

DASAMI LAB PRIVATE LTDAMINOCAPROIC ACID

DMF 329702021

MSN LIFE SCIENCES PRIVATE LTDAMINOCAPROIC ACID USP

DMF 331342018

OPTIMUS DRUGS PRIVATE LTDAMINOCAPROIC ACID

DMF 334072018

EMCURE PHARMACEUTICALS LTDAMINOCAPROIC ACID USP

DMF 343272020

SUNNY PHARMTECH INCAMINOCAPROIC ACID USP

DMF 343862020

MICRO LABS LTDAMINOCAPROIC ACID USP

DMF 350692020

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2008	SUPPL -43	View Letter (PDF)
Aug 25, 2004	SUPPL -40	View Letter (PDF)
Jun 25, 2004	SUPPL -36	View Letter (PDF)
Jun 25, 2004	SUPPL -37	View Letter (PDF)
Jun 25, 2004	SUPPL -39	View Letter (PDF)
Jun 25, 2004	SUPPL -38	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 1GM

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 24, 2004