GUANABENZ ACETATE - Generic Drug Details
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What are the generic sources for guanabenz acetate and what is the scope of freedom to operate?
Guanabenz acetate
is the generic ingredient in two branded drugs marketed by Ani Pharms, Chartwell Rx, Watson Labs, and Wyeth Ayerst, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for guanabenz acetate.
Summary for GUANABENZ ACETATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 3 |
| Patent Applications: | 1,190 |
| DailyMed Link: | GUANABENZ ACETATE at DailyMed |
Recent Clinical Trials for GUANABENZ ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yokohama City University | Phase 2 |
| Kathy Miller | N/A |
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 1 |
Medical Subject Heading (MeSH) Categories for GUANABENZ ACETATE
US Patents and Regulatory Information for GUANABENZ ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wyeth Ayerst | WYTENSIN | guanabenz acetate | TABLET;ORAL | 018587-003 | Sep 7, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | GUANABENZ ACETATE | guanabenz acetate | TABLET;ORAL | 074267-002 | Jun 1, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wyeth Ayerst | WYTENSIN | guanabenz acetate | TABLET;ORAL | 018587-001 | Sep 7, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | GUANABENZ ACETATE | guanabenz acetate | TABLET;ORAL | 074517-002 | Sep 30, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | GUANABENZ ACETATE | guanabenz acetate | TABLET;ORAL | 074267-001 | Jun 1, 1994 | 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 GUANABENZ ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wyeth Ayerst | WYTENSIN | guanabenz acetate | TABLET;ORAL | 018587-001 | Sep 7, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Ayerst | WYTENSIN | guanabenz acetate | TABLET;ORAL | 018587-003 | Sep 7, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Ayerst | WYTENSIN | guanabenz acetate | TABLET;ORAL | 018587-002 | Sep 7, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
