GYNAZOLE-1 Drug Patent Profile
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Which patents cover Gynazole-1, and when can generic versions of Gynazole-1 launch?
Gynazole-1 is a drug marketed by Padagis Israel and is included in one NDA.
The generic ingredient in GYNAZOLE-1 is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.
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Summary for GYNAZOLE-1
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 165 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,009 |
| DailyMed Link: | GYNAZOLE-1 at DailyMed |
Recent Clinical Trials for GYNAZOLE-1
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Perrigo Company | N/A |
| Padagis LLC | N/A |
Pharmacology for GYNAZOLE-1
| Drug Class | Azole Antifungal |
US Patents and Regulatory Information for GYNAZOLE-1
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | GYNAZOLE-1 | butoconazole nitrate | CREAM;VAGINAL | 200923-001 | May 18, 2012 | RX | No | 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 |
