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Last Updated: April 16, 2024

Midazolam hydrochloride - Generic Drug Details

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What are the generic sources for midazolam hydrochloride and what is the scope of freedom to operate?

Midazolam hydrochloride is the generic ingredient in six branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, 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 NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-four 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:	24
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1,455
Patent Applications:	1,589
Formulation / Manufacturing:	see details
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
Abraham Nunes	Phase 3
Nova Scotia Health Authority	Phase 3
National Trauma Center	N/A

See all midazolam hydrochloride clinical trials

Generic filers with tentative approvals for MIDAZOLAM HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	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

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
Padagis Us	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	076379-001	May 2, 2005	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075481-001	Jun 30, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	075873-001	Apr 30, 2002	AA	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	212847-001	Dec 11, 2020	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998	⤷ Try a Trial	⤷ Try a Trial
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987	⤷ Try a Trial	⤷ Try a Trial
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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