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.
Summary for ANTARA (MICRONIZED)
| International Patents: | 2 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 127 |
| Patent Applications: | 4,041 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANTARA (MICRONIZED) |
| DailyMed Link: | ANTARA (MICRONIZED) at DailyMed |
-patent-expirations.png "ANTARA (MICRONIZED) drug patent expirations")
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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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 verification 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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