MIDAZOLAM HYDROCHLORIDE Drug Patent Profile
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When do Midazolam Hydrochloride patents expire, and what generic alternatives are available?
Midazolam Hydrochloride is a drug 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, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, and Steriscience Speclts. and is included in thirty-six NDAs.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Midazolam Hydrochloride
A generic version of MIDAZOLAM HYDROCHLORIDE was approved as midazolam hydrochloride by FRESENIUS KABI USA on June 20th, 2000.
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Questions you can ask:
- What is the 5 year forecast for MIDAZOLAM HYDROCHLORIDE?
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Summary for MIDAZOLAM HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 1,499 |
| Patent Applications: | 1,069 |
| 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 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intl Medication | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 076020-001 | Jul 16, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075293-002 | Jun 20, 2000 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pharm Assoc | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 077115-001 | Sep 9, 2005 | 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 |
