FLURAZEPAM HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for flurazepam hydrochloride and what is the scope of freedom to operate?
Flurazepam hydrochloride
is the generic ingredient in two branded drugs marketed by Valeant Pharm Intl, Chartwell Rx, Halsey, Hikma, Hikma Intl Pharms, Purepac Pharm, Rising, Strides Pharma, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for flurazepam hydrochloride. One supplier is listed for this compound.
Summary for FLURAZEPAM HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 23 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 28 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,302 |
| What excipients (inactive ingredients) are in FLURAZEPAM HYDROCHLORIDE? | FLURAZEPAM HYDROCHLORIDE excipients list |
| DailyMed Link: | FLURAZEPAM HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for FLURAZEPAM HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Saint-Joseph University | Phase 3 |
| Hannover Medical School | Phase 3 |
| Eisai Inc. | Phase 1 |
Pharmacology for FLURAZEPAM HYDROCHLORIDE
| Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for FLURAZEPAM HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for FLURAZEPAM HYDROCHLORIDE
US Patents and Regulatory Information for FLURAZEPAM HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | FLURAZEPAM HYDROCHLORIDE | flurazepam hydrochloride | CAPSULE;ORAL | 070345-002 | Nov 27, 1985 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Usl Pharma | FLURAZEPAM HYDROCHLORIDE | flurazepam hydrochloride | CAPSULE;ORAL | 070562-001 | Jul 9, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Purepac Pharm | FLURAZEPAM HYDROCHLORIDE | flurazepam hydrochloride | CAPSULE;ORAL | 071551-001 | Sep 9, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | FLURAZEPAM HYDROCHLORIDE | flurazepam hydrochloride | CAPSULE;ORAL | 070345-001 | Nov 27, 1985 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | FLURAZEPAM HYDROCHLORIDE | flurazepam hydrochloride | CAPSULE;ORAL | 071717-001 | Jul 31, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Pharm Intl | DALMANE | flurazepam hydrochloride | CAPSULE;ORAL | 016721-001 | Approved Prior to Jan 1, 1982 | 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 FLURAZEPAM HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Pharm Intl | DALMANE | flurazepam hydrochloride | CAPSULE;ORAL | 016721-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharm Intl | DALMANE | flurazepam hydrochloride | CAPSULE;ORAL | 016721-002 | Approved Prior to Jan 1, 1982 | ⤷ 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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