Midazolam - Generic Drug Details

What are the generic drug sources for midazolam and what is the scope of patent protection?

Midazolam is the generic ingredient in nine branded drugs marketed by Exela Pharma, Hikma, Inforlife, Ucb Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Pai Holdings, Rising, Steriscience, HLR, Rafa Labs Ltd, MMT, Akorn, Padagis Us, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in forty-four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for midazolam

US Patents:	5
Tradenames:	9
Applicants:	28
NDAs:	44
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1,455
Patent Applications:	7,028
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for midazolam
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for midazolam
What excipients (inactive ingredients) are in midazolam?	midazolam excipients list
DailyMed Link:	midazolam at DailyMed

See drug prices for midazolam

Recent Clinical Trials for midazolam

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

Sponsor	Phase
Abraham Nunes	Phase 3
Nova Scotia Health Authority	Phase 3
National Trauma Center	N/A

See all midazolam clinical trials

Generic filers with tentative approvals for MIDAZOLAM

Applicant	Application No.	Strength	Dosage Form
		EQ 5MG BASE/ML	INJECTABLE;INJECTION
		5MG	SPRAY;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for midazolam

Drug Class

Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for midazolam

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for MIDAZOLAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAYZILAM	Nasal Spray	midazolam	5 mg/spray	211321	1	2021-06-01

US Patents and Regulatory Information for midazolam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	090315-002	Nov 29, 2010	AP	RX	No	No
Sun Pharm Inds Ltd	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	076058-001	Mar 15, 2002		DISCN	No	No
Intl Medication	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	076020-002	Jul 16, 2004		DISCN	No	No
Apothecon	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075620-001	Nov 1, 2000		DISCN	No	No
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987		DISCN	Yes	No
Baxter Hlthcare Corp	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075637-001	Oct 31, 2000		DISCN	No	No
Hospira	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075293-001	Jun 20, 2000	AP	RX	No	Yes

EU/EMA Drug Approvals for midazolam

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Neuraxpharm Pharmaceuticals S.L.	Buccolam	midazolam	EMEA/H/C/002267 Treatment 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