FLUCONAZOLE Drug Patent Profile
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Which patents cover Fluconazole, and what generic alternatives are available?
Fluconazole is a drug marketed by Aurobindo Pharma, Hainan Poly, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Norvium Bioscience, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, Zydus Pharms, Hikma Farmaceutica, Hospira, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, Mylan Labs Ltd, and West-ward Pharms Int. and is included in forty-two NDAs.
The generic ingredient in FLUCONAZOLE is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluconazole
A generic version of FLUCONAZOLE was approved as fluconazole by CHARTWELL on July 29th, 2004.
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Questions you can ask:
- What is the 5 year forecast for FLUCONAZOLE?
- What are the global sales for FLUCONAZOLE?
- What is Average Wholesale Price for FLUCONAZOLE?
Summary for FLUCONAZOLE
| US Patents: | 0 |
| Applicants: | 31 |
| NDAs: | 42 |
| Finished Product Suppliers / Packagers: | 39 |
| Raw Ingredient (Bulk) Api Vendors: | 158 |
| Clinical Trials: | 274 |
| Patent Applications: | 4,236 |
| Drug Prices: | Drug price information for FLUCONAZOLE |
| Drug Sales Revenues: | Drug sales revenues for FLUCONAZOLE |
| What excipients (inactive ingredients) are in FLUCONAZOLE? | FLUCONAZOLE excipients list |
| DailyMed Link: | FLUCONAZOLE at DailyMed |
See drug prices for FLUCONAZOLE
Recent Clinical Trials for FLUCONAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alexion Pharmaceuticals, Inc. | Phase 1 |
| Huashan Hospital | Phase 4 |
| FEMPHARMA Kft. | N/A |
Pharmacology for FLUCONAZOLE
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUCONAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for FLUCONAZOLE
US Patents and Regulatory Information for FLUCONAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | FLUCONAZOLE | fluconazole | TABLET;ORAL | 074681-001 | Jul 29, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma Farmaceutica | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | fluconazole | INJECTABLE;INJECTION | 076736-001 | Aug 23, 2005 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ivax Sub Teva Pharms | FLUCONAZOLE | fluconazole | TABLET;ORAL | 076077-002 | Jul 29, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gedeon Richter Usa | FLUCONAZOLE | fluconazole | TABLET;ORAL | 076432-001 | Jul 29, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 076304-001 | Jul 29, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Labs Ltd | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 076889-001 | Mar 25, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Pharms Inc | FLUCONAZOLE | fluconazole | TABLET;ORAL | 076042-002 | Jul 29, 2004 | 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 |
