FENOGLIDE Drug Patent Profile

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-three 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.

Summary for FENOGLIDE

International Patents:	29
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	1
Patent Applications:	4,057
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FENOGLIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENOGLIDE
What excipients (inactive ingredients) are in FENOGLIDE?	FENOGLIDE excipients list
DailyMed Link:	FENOGLIDE at DailyMed

See drug prices for FENOGLIDE

See drug sales revenues for FENOGLIDE

Recent Clinical Trials for FENOGLIDE

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

Sponsor	Phase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
The Scripps Research Institute	Phase 2

See all FENOGLIDE clinical trials

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

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

International Patents for FENOGLIDE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2582403	COMPOSITIONS PHARMACEUTIQUES COMPRENANT DU FENOFIBRATE ET DEL'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN)
World Intellectual Property Organization (WIPO)	2006037347
Japan	2007508249
Canada	2541382	FORME POSOLOGIQUE SOLIDE COMPRENANT UNE FIBRATE ET UNE STATINE (A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN)
China	1867321	A solid dosage form comprising a fibrate
Hong Kong	1096034	A SOLID DOSAGE FORM COMPRISING A FIBRATE