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-one 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:	1
Patent Applications:	4,134
Formulation / Manufacturing:	see details
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
The Scripps Research Institute	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

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Pharmacology for FENOGLIDE

Drug Class	Peroxisome Proliferator Receptor alpha Agonist

Anatomical Therapeutic Chemical (ATC) Classes for FENOGLIDE

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Tablet comprising a fibrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a 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

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

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Country	Patent Number	Title	Estimated Expiration
Japan	5069001		⤷ Try a Trial
European Patent Office	1680091	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006037344		⤷ Try a Trial
Canada	2540984	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)	⤷ Try a Trial
Russian Federation	2343905	ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН (SOLID DOSED OUT FORMS INCLUDING FIBRAT AND STATIN)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration