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, 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 |
Generic filers with tentative approvals for MIDAZOLAM HYDROCHLORIDE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 078141-002 | May 30, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Micro Labs | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 217504-001 | Aug 21, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Intl Medication | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 076020-002 | Jul 16, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hlr | VERSED | midazolam hydrochloride | INJECTABLE;INJECTION | 018654-002 | May 26, 1987 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 078511-001 | Nov 10, 2008 | 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
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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