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Last Updated: January 21, 2021

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ANTARA (MICRONIZED) Drug 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 four patents protecting this drug.

This drug has ninety-seven patent family members in thirty-eight countries.

The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Additional details are available on the fenofibrate profile page.

US ANDA 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 NDA Submissiondate
ANTARA (MICRONIZED) CAPSULE;ORAL fenofibrate 021695 2008-09-15

US Patents and Regulatory Information for ANTARA (MICRONIZED)

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   Start Trial   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004 AB RX Yes No   Start Trial   Start Trial Y Y   Start 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 021695-002 Nov 30, 2004   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004   Start Trial   Start Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
AstraZeneca
Baxter
Mallinckrodt
Harvard Business School

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