Viewing data from:

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Amicar (2023)

Total Spending

$60K

Total Claims

Beneficiaries

Avg Cost/Unit

$18.31

Spending Trend

$3.6M(2019)→$988K(2020)→$550K(2021)→$370K(2022)→$60K(2023)

YoY Change:+1.2%

5yr CAGR:+1.8%

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

API Supply Chain8 active DMFs

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

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