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MIDAZOLAM IN 0.9% SODIUM CHLORIDE

NDA

MIDAZOLAM | N211844 | INFORLIFE SA

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

10966990

Jun. 20, 2038

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
InfoRLife SA et al v. Sun Pharmaceutical Industries Limited et al 1:2021cv01740 1 patentmidazolam	D. Del.	2021-12-10	Terminated 2023-02-28	—

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

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 DMFs4 inactive

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

WAVELENGTH ENTERPRISES LTDMIDAZOLAM

DMF 125531997

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM

DMF 126861997

FIS FABBRICA ITALIANA SINTETICI SPAMIDAZOLAM HCI

DMF 252042011

COHANCE LIFESCIENCES LTDMIDAZOLAM USP

DMF 268712013

SOLARA ACTIVE PHARMA SCIENCES LTDMIDAZOLAM

DMF 298812015

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM MALEATE

DMF 371022022

GLOBAL CALCIUM PRIVATE LTDMIDAZOLAM USP

DMF 393652024

SUPRIYA LIFESCIENCE LTDMIDAZOLAM USP

DMF 432712025

ABBOTT LABORATORIES HOSP PRODUCTS DIVInactiveMIDAZOLAM

DMF 127451997

DIOSYNTH BVInactiveMIDAZOLAM

DMF 129101998

PCASInactiveMIDAZOLAM BASE

DMF 129291998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMIDAZOLAM (NON-STERILE BULK) USP

DMF 151702000

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -4	View Letter (PDF)
Oct 20, 2021	SUPPL -1	View Letter (PDF)
Mar 24, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/50ML (1MG/ML)

RLDAP

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 22, 2021

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10966990	Jun 20, 2038	—	—	Yes	—	—

#002 — 100MG/100ML (1MG/ML)

RLDAP

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 22, 2021