ANTARA (MICRONIZED) Drug Patent Profile

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When do Antara (micronized) patents expire, and when can generic versions of Antara (micronized) launch?

Antara (micronized) is a drug marketed by Lupin and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in ANTARA (MICRONIZED) 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 Antara (micronized)

A generic version of ANTARA (MICRONIZED) was approved as fenofibrate by RHODES PHARMS on May 13^th, 2005.

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Summary for ANTARA (MICRONIZED)

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Patent Applications:	2,943
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANTARA (MICRONIZED)
DailyMed Link:	ANTARA (MICRONIZED) at DailyMed

Drug patent expirations by year for ANTARA (MICRONIZED)

Pharmacology for ANTARA (MICRONIZED)

Drug Class	Peroxisome Proliferator Receptor alpha Agonist

Anatomical Therapeutic Chemical (ATC) Classes for ANTARA (MICRONIZED)

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

Paragraph IV (Patent) Challenges for ANTARA (MICRONIZED)

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANTARA (MICRONIZED)	Capsules	fenofibrate	43 mg and 130 mg	021695	1	2008-09-15

US Patents and Regulatory Information for ANTARA (MICRONIZED)

ANTARA (MICRONIZED) is protected by four US patents.

Patents protecting ANTARA (MICRONIZED)

Treating metabolic syndrome with fenofibrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING SEVERE HYPERTRIGLYCERIDEMIA

Treating metabolic syndrome with fenofibrate
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Reduced dose pharmaceutical compositions of fenofibrate
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Reduced dose pharmaceutical compositions of fenofibrate
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATING SEVERE HYPERTRIGLYCERIDEMIA

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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
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-004	Oct 18, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	AB	RX	Yes	Yes	⤷ 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

Expired US Patents for ANTARA (MICRONIZED)

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ANTARA (MICRONIZED)

See the table below for patents covering ANTARA (MICRONIZED) around the world.

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Country	Patent Number	Title	Estimated Expiration
Estonia	04995	Fenofibraati sisaldav farmatseutiline kompositsioon ja meetod selle valmistamiseks	⤷ Sign Up
South Africa	200200169	Pharmaceutical composition containing fenofibrate and method for the preparation thereof.	⤷ Sign Up
Japan	2003504331		⤷ Sign Up
Estonia	200200011	Fenofibraati sisaldav farmatseutiline kompositsioon ja meetod selle valmistamiseks	⤷ Sign Up
Norway	335933		⤷ Sign Up
European Patent Office	1667666	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET SON PROCEDE DE PREPARATION (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND METHOD FOR THE PREPARATION THEREOF)	⤷ Sign Up
Mexico	PA02000324	COMPOSICION FARMACEUTICA QUE CONTIENE FENOFIBRATO Y UN METODO PARA LA PREPARACION DE LA MISMA. (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for ANTARA (MICRONIZED)

Pharmacology for ANTARA (MICRONIZED)

Anatomical Therapeutic Chemical (ATC) Classes for ANTARA (MICRONIZED)

Paragraph IV (Patent) Challenges for ANTARA (MICRONIZED)

Patents protecting ANTARA (MICRONIZED)

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