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Serving leading biopharmaceutical companies globally:

McKinsey
Chubb
Citi
Fish and Richardson
Moodys
Federal Trade Commission
Express Scripts
Teva
Julphar
Cantor Fitzgerald

Generated: November 19, 2017

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 two suppliers. 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 021695

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Cardiovascular Agents
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 PHARMA 27437-107 27437-107-06 30 CAPSULE in 1 BOTTLE (27437-107-06)
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL 021695 NDA LUPIN PHARMA 27437-107 27437-107-19 7 CAPSULE in 1 BOTTLE (27437-107-19)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 021695

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-001Nov 30, 2004► Subscribe► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-002Nov 30, 2004► Subscribe► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 30, 2004► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Teva
Boehringer Ingelheim
Novartis
Deloitte
Healthtrust
McKinsey
UBS
US Department of Justice
Farmers Insurance

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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