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, 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-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: | 1,455 |
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 |
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
Anatomical Therapeutic Chemical (ATC) Classes for midazolam hydrochloride
US Patents and Regulatory Information for midazolam hydrochloride
Expired US Patents for midazolam hydrochloride
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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