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Last Updated: May 19, 2022

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING SEVERE HYPERTRIGLYCERIDEMIA

Treating metabolic syndrome with fenofibrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Reduced dose pharmaceutical compositions of fenofibrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Reduced dose pharmaceutical compositions of fenofibrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 021695-001 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
>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
Germany 60039313 See Plans and Pricing
Japan 2011148813 PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE, AND METHOD FOR PREPARING THE SAME See Plans and Pricing
Norway 333301 See Plans and Pricing
Hong Kong 1074588 Aqueous suspension comprising fenofibrate See Plans and Pricing
Norway 174876 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
AstraZeneca
Baxter
Mallinckrodt
Harvard Business School

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