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: | 137 |
Patent Applications: | 3,953 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANTARA (MICRONIZED) |
DailyMed Link: | ANTARA (MICRONIZED) at DailyMed |
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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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING SEVERE HYPERTRIGLYCERIDEMIA
Treating metabolic syndrome with fenofibrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
Reduced dose pharmaceutical compositions of fenofibrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
Reduced dose pharmaceutical compositions of fenofibrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-005 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-005 | Oct 18, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 021695-003 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
South Africa | 200603504 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ⤷ Try a Trial |
Cyprus | 1109929 | ⤷ Try a Trial | |
European Patent Office | 1194140 | COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET PROCEDE DE PREPARATION (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD) | ⤷ Try a Trial |
China | 1682707 | Pharmaceutical composition comprising fenofibrate and process for its preparation | ⤷ Try a Trial |
Portugal | 1574214 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0103693 | ⤷ Try a Trial | |
Denmark | 175867 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |