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FENOGLIDE Drug Profile
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Which patents cover Fenoglide, and what generic alternatives are available?
Fenoglide is a drug marketed by Salix and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-nine patent family members in eleven countries.
The generic ingredient in FENOGLIDE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
US ANDA Litigation and Generic Entry Outlook for Fenoglide
A generic version of FENOGLIDE was approved as fenofibrate by RHODES PHARMS on May 13th, 2005.
Summary for FENOGLIDE
| International Patents: | 29 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 117 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,450 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FENOGLIDE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FENOGLIDE |
| DailyMed Link: | FENOGLIDE at DailyMed |
Paragraph IV (Patent) Challenges for FENOGLIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FENOGLIDE | TABLET;ORAL | fenofibrate | 022118 | 2010-03-17 |
US Patents and Regulatory Information for FENOGLIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-002 | Aug 10, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-002 | Aug 10, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FENOGLIDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1867321 | Start Trial |
| European Patent Office | 1804769 | Start Trial |
| China | 1874758 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005034920 | Start Trial |
| Japan | 5069001 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
