MIDAZOLAM IN 0.9% SODIUM CHLORIDE Drug Patent Profile

Which patents cover Midazolam In 0.9% Sodium Chloride, and what generic alternatives are available?

Midazolam In 0.9% Sodium Chloride is a drug marketed by Gland, Hikma, and Inforlife. and is included in three NDAs. There is one patent protecting this drug.

The generic ingredient in MIDAZOLAM IN 0.9% SODIUM CHLORIDE is midazolam. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.

DrugPatentWatch^® Generic Entry Outlook for Midazolam In 0.9% Sodium Chloride

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (midazolam), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

US Patents:	1
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Clinical Trials:	1,722
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
DailyMed Link:	MIDAZOLAM IN 0.9% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis Pharmaceuticals	PHASE1
University Health Network, Toronto	PHASE3
Canadian Institutes of Health Research (CIHR)	PHASE3

See all MIDAZOLAM IN 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Drug Class

Benzodiazepine

US Patents and Regulatory Information for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

MIDAZOLAM IN 0.9% SODIUM CHLORIDE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993-001	Aug 12, 2024	AP	RX	No	No
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-002	Apr 17, 2023	AP	RX	No	No
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993-002	Aug 12, 2024	AP	RX	No	No
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-001	Apr 17, 2023	AP	RX	No	No
Inforlife	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	211844-002	Mar 22, 2021	AP	RX	Yes	Yes	10,966,990		Y
Inforlife	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	211844-001	Mar 22, 2021	AP	RX	Yes	Yes	10,966,990		Y

EU/EMA Drug Approvals for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Neuraxpharm Pharmaceuticals S.L.	Buccolam	midazolam	EMEA/H/C/002267Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.	Authorised	no	no	no	2011-09-04