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ANTARA (MICRONIZED) Drug 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 four patents protecting this drug.
This drug has ninety-seven patent family members in thirty-eight countries.
The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Additional details are available on the fenofibrate profile page.
US ANDA 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: | 97 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 124 |
| 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 | NDA | Submissiondate |
|---|---|---|---|---|
| ANTARA (MICRONIZED) | CAPSULE;ORAL | fenofibrate | 021695 | 2008-09-15 |
US Patents and Regulatory Information for ANTARA (MICRONIZED)
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-005 | Oct 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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 | 021695-002 | Nov 30, 2004 | Start Trial | Start Trial |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | Start Trial | Start Trial |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | Start Trial | Start Trial |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | Start Trial | Start Trial |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANTARA (MICRONIZED)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1574214 | Start Trial |
| Norway | 873320 | Start Trial |
| Montenegro | 01361 | Start Trial |
| Hong Kong | 1080391 | Start Trial |
| Portugal | 1523983 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
