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MIDAZOLAM HYDROCHLORIDE - Generic Drug Details
What are the generic sources for midazolam hydrochloride and what is the scope of midazolam hydrochloride freedom to operate?
Midazolam hydrochloride
is the generic ingredient in five branded drugs marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, West-ward Pharms Int, Wockhardt, Mylan Asi, Sagent Strides, HLR, Meridian Medcl Techn, Apotex Inc, Hi Tech Pharma, Paddock Llc, Sun Pharm Inds Ltd, and Roche, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for midazolam hydrochloride. Twenty-three suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for MIDAZOLAM HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 23 |
| NDAs: | 37 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 23 |
| Bulk Api Vendors: | 26 |
| Clinical Trials: | 915 |
| Patent Applications: | 1,284 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MIDAZOLAM HYDROCHLORIDE at DailyMed |
Pharmacology for MIDAZOLAM HYDROCHLORIDE
| Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for MIDAZOLAM HYDROCHLORIDE
Synonyms for MIDAZOLAM HYDROCHLORIDE
| 3849AH |
| 467M968 |
| 4H-Imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, hydrochloride |
| 4H-Imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, monohydrochloride |
| 4H-Imidazo[1,5a][1,4]benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, hydrochloride |
| 59467-96-8 |
| 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepine hydrochloride |
| 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepine monohydrochloride |
| 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride |
| 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine;hydrochloride |
| 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5a][1,4]benzodiazepine hydrochloride |
| AC1L290O |
| AKOS024457308 |
| Ambap59467-96-8 |
| AN-39559 |
| API0003386 |
| C18H13ClFN3.ClH |
| C18H13ClFN3.HCl |
| CAS-59467-96-8 |
| CCG-100983 |
| CHEBI:6932 |
| CHEMBL1200420 |
| CPD000469160 |
| CS-2908 |
| D00696 |
| Dormicum |
| DSSTox_CID_27824 |
| DSSTox_GSID_47846 |
| DSSTox_RID_82587 |
| DTXSID8047846 |
| EINECS 261-776-6 |
| HSDB 6751 |
| HY-B0676A |
| Hypnovel |
| Hypnovel hydrochloride |
| KB-74241 |
| LS-77782 |
| MFCD00864445 |
| Midazolam (hydrochloride) |
| Midazolam Hcl |
| Midazolam hydrochloride (USAN) |
| Midazolam hydrochloride [USAN] |
| Midazolam hydrochloride preservative free |
| MLS001401415 |
| NC00233 |
| NCGC00168254-01 |
| NCGC00168254-02 |
| NSC-751451 |
| NSC751451 |
| Ro 21-3981/001 |
| Ro 21-3981/003 |
| Ro-213981-003 |
| Ro-213981003 |
| Rocam |
| SAM001246585 |
| SC-47268 |
| SCHEMBL41265 |
| SMR000469160 |
| TL8003788 |
| Tox21_112613 |
| Tox21_112613_1 |
| UNII-W7TTW573JJ |
| Versed (TN) |
| Versed hydrochloride |
| W7TTW573JJ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075637-002 | Oct 31, 2000 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Bedford | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075249-001 | Jun 23, 2000 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Baxter Hlthcare Corp | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075637-001 | Oct 31, 2000 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Apotex Inc | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 077115-001 | Sep 9, 2005 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Apothecon | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075641-001 | Oct 19, 2000 | 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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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