MIDAZOLAM Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Midazolam, and when can generic versions of Midazolam launch?
Midazolam is a drug 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, Ph Health, Rising, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, Onesource Specialty, B Braun Medical, Exela Pharma, Gland, and Inforlife. and is included in forty-one NDAs. There is one patent protecting this drug.
The generic ingredient in MIDAZOLAM is midazolam. There are nine drug master file entries 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
There have been five 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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for MIDAZOLAM?
- What are the global sales for MIDAZOLAM?
- What is Average Wholesale Price for MIDAZOLAM?
Summary for MIDAZOLAM
| US Patents: | 0 |
| Applicants: | 26 |
| NDAs: | 41 |
| Drug Prices: | Drug price information for MIDAZOLAM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIDAZOLAM |
| DailyMed Link: | MIDAZOLAM at DailyMed |
Recent Clinical Trials for MIDAZOLAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | PHASE1 |
| Canadian Institutes of Health Research (CIHR) | PHASE3 |
| Unity Health Toronto | PHASE3 |
Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ph Health | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 078511-001 | Nov 10, 2008 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hospira Inc | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075409-001 | Jun 20, 2000 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Pharm Assoc | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 077115-001 | Sep 9, 2005 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Exela Pharma | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868-001 | Jul 20, 2022 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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/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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
