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ANTARA (MICRONIZED) Drug Profile

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Antara (micronized) is a drug marketed by Lupin Atlantis and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug.

This drug has eighty-two patent family members in thirty-seven countries.

The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the fenofibrate profile page.

Summary for Tradename: ANTARA (MICRONIZED)

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: ANTARA (MICRONIZED)

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-004Oct 18, 2013RXNo8,026,281► subscribe ► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-005Oct 18, 2013RXNo9,314,447► subscribeY ► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-001Nov 30, 2004RXNo7,863,331► subscribe ► subscribe
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Expired Patents for Tradename: ANTARA (MICRONIZED)

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-001Nov 30, 20044,800,079► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 30, 20044,800,079► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-002Nov 30, 20044,800,079► subscribe
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Non-Orange Book Patents for Tradename: ANTARA (MICRONIZED)

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,529,952Pharmaceutical composition containing fenofibrate and method for the preparation thereof► subscribe
8,658,212Pharmaceutical composition containing fenofibrate and method for the preparation thereof► subscribe
8,563,042Pharmaceutical composition containing fenofibrate and method for the preparation thereof► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ANTARA (MICRONIZED)

Country Document Number Estimated Expiration
New Zealand516416► subscribe
Hungary0202338► subscribe
Hungary229044► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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