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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021695


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NDA 021695 describes ANTARA (MICRONIZED), which is a drug marketed by Lupin Atlantis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ANTARA (MICRONIZED) profile page.

The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021695
Tradename:ANTARA (MICRONIZED)
Applicant:Lupin Atlantis
Ingredient:fenofibrate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021695
Medical Subject Heading (MeSH) Categories for 021695
Suppliers and Packaging for NDA: 021695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695 NDA Lupin Pharmaceuticals, Inc. 27437-107 27437-107-06 30 CAPSULE in 1 BOTTLE (27437-107-06)
ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695 NDA Lupin Pharmaceuticals, Inc. 27437-107 27437-107-19 7 CAPSULE in 1 BOTTLE (27437-107-19)
Paragraph IV (Patent) Challenges for 021695
Tradename Dosage Ingredient NDA Submissiondate
ANTARA (MICRONIZED) CAPSULE;ORAL fenofibrate 021695 2008-09-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Nov 30, 2004TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Aug 20, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Aug 8, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING HYPERCHOLESTEROLEMIAS WITH REDUCTION OF FOOD EFFECT
Patent:  Start TrialPatent Expiration:Aug 8, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING HYPERTRIGLYCERIDEMIAS WITH REDUCTION OF FOOD EFFECT

Expired US Patents for NDA 021695

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

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