Viewing data from:

AMICAR

NDA

AMINOCAPROIC ACID | N015230 | HIKMA PHARMACEUTICALS USA 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

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

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

Source: Drugs@FDA application documents.

Products (1)

#002 — 0.25GM/ML

RLDAA

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.