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Last Updated: June 9, 2023

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-three 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 13th, 2005.

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SEVERE HYPERTRIGLYCERIDEMIA

Treating metabolic syndrome with fenofibrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Reduced dose pharmaceutical compositions of fenofibrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Reduced dose pharmaceutical compositions of fenofibrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SEVERE HYPERTRIGLYCERIDEMIA

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

Expired US Patents for ANTARA (MICRONIZED)

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

Country Patent Number Title Estimated Expiration
South Africa 200603504 Pharmaceutical composition containing fenofibrate and method for the preparation thereof ⤷  Try a Trial
Cyprus 1109929 ⤷  Try a Trial
European Patent Office 1194140 COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET PROCEDE DE PREPARATION (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD) ⤷  Try a Trial
China 1682707 Pharmaceutical composition comprising fenofibrate and process for its preparation ⤷  Try a Trial
Portugal 1574214 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 0103693 ⤷  Try a Trial
Denmark 175867 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
AstraZeneca
Baxter
Mallinckrodt
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.