Midazolam hydrochloride - Generic Drug Details

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

Midazolam hydrochloride is the generic ingredient in six branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Endo Operations, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Rising, Steriscience Speclts, HLR, Rafa Labs Ltd, MMT, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for midazolam hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	25
NDAs:	40
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1,499
Patent Applications:	1,566
What excipients (inactive ingredients) are in midazolam hydrochloride?	midazolam hydrochloride excipients list
DailyMed Link:	midazolam hydrochloride at DailyMed

Recent Clinical Trials for midazolam hydrochloride

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Medical University of South Carolina	Phase 4
Ruijin Hospital	Phase 1/Phase 2

See all midazolam hydrochloride clinical trials

Generic filers with tentative approvals for MIDAZOLAM HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 5MG BASE/ML	INJECTABLE;INJECTION

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 hydrochloride

Drug Class	Benzodiazepine

Medical Subject Heading (MeSH) Categories for midazolam hydrochloride

Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for midazolam hydrochloride

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

US Patents and Regulatory Information for midazolam hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience Speclts	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	090315-002	Nov 29, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075243-002	Jun 20, 2000	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	212847-002	Dec 11, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075856-002	Jun 13, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for midazolam hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987	⤷ Sign Up	⤷ Sign Up
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998	⤷ Sign Up	⤷ Sign Up
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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