QUAZEPAM - Generic Drug Details
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What are the generic drug sources for quazepam and what is the scope of freedom to operate?
Quazepam
is the generic ingredient in one branded drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for quazepam. One supplier is listed for this compound.
Summary for QUAZEPAM
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 1 |
| What excipients (inactive ingredients) are in QUAZEPAM? | QUAZEPAM excipients list |
| DailyMed Link: | QUAZEPAM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QUAZEPAM
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for QUAZEPAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Saint-Joseph University | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for QUAZEPAM
US Patents and Regulatory Information for QUAZEPAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | RX | Yes | Yes | ⤷ 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 QUAZEPAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
