FENOGLIDE Drug Patent 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fenoglide

A generic version of FENOGLIDE was approved as fenofibrate by RHODES PHARMS on May 13^th, 2005.

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Summary for FENOGLIDE

International Patents:	29
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	2
Patent Applications:	4,098
Drug Prices:	Drug price information for FENOGLIDE
What excipients (inactive ingredients) are in FENOGLIDE?	FENOGLIDE excipients list
DailyMed Link:	FENOGLIDE at DailyMed

Drug patent expirations by year for FENOGLIDE

Recent Clinical Trials for FENOGLIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lindsay Ferguson, MD	Phase 1
The Scripps Research Institute	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

See all FENOGLIDE clinical trials

Pharmacology for FENOGLIDE

Drug Class	Peroxisome Proliferator Receptor alpha Agonist

Paragraph IV (Patent) Challenges for FENOGLIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FENOGLIDE	Tablets	fenofibrate	40 mg and 120 mg	022118	1	2010-03-17

US Patents and Regulatory Information for FENOGLIDE

FENOGLIDE is protected by four US patents.

Patents protecting FENOGLIDE

Solid dosage form comprising a fibrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid dosage form comprising a fibrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA

Solid dosage form comprising a fibrate
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Patent Expiration: ⤷ Sign Up
Patented Use: USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES

Tablet comprising a fibrate
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Glossary

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 FENOGLIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FENOGLIDE

See the table below for patents covering FENOGLIDE around the world.

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Country	Patent Number	Title	Estimated Expiration
China	1874758	Compositions comprising fenofibrate and pravastatin	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005034908		⤷ Sign Up
Russian Federation	2343905	ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН (SOLID DOSED OUT FORMS INCLUDING FIBRAT AND STATIN)	⤷ Sign Up
Russian Federation	2006115596	ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН	⤷ Sign Up
European Patent Office	1818049	Atorvastatin stabilisée (Stabilized Atorvastatin)	⤷ Sign Up
Canada	2540984	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration