FENOFIBRATE (MICRONIZED) Drug Patent Profile
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Which patents cover Fenofibrate (micronized), and when can generic versions of Fenofibrate (micronized) launch?
Fenofibrate (micronized) is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Reyoung, Rhodes Pharms, Rising, Torrent, and Youngtech Pharms Inc. and is included in sixteen NDAs.
The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fenofibrate (micronized)
A generic version of FENOFIBRATE (MICRONIZED) was approved as fenofibrate by RHODES PHARMS on May 13th, 2005.
Summary for FENOFIBRATE (MICRONIZED)
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,839 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FENOFIBRATE (MICRONIZED) at DailyMed |
-patent-expirations.png "FENOFIBRATE (MICRONIZED) drug patent expirations")
Recent Clinical Trials for FENOFIBRATE (MICRONIZED)
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beijing Chao Yang Hospital | Phase 4 |
| Hanlim Pharm. Co., Ltd. | Phase 1 |
| University of Ioannina | Phase 4 |
Pharmacology for FENOFIBRATE (MICRONIZED)
Anatomical Therapeutic Chemical (ATC) Classes for FENOFIBRATE (MICRONIZED)
US Patents and Regulatory Information for FENOFIBRATE (MICRONIZED)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210782-002 | Jun 26, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Reyoung | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207805-002 | Nov 16, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Youngtech Pharms Inc | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 211407-003 | Jan 31, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novast Labs | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207564-001 | Apr 19, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Reyoung | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207805-003 | Nov 16, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novast Labs | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207564-002 | Apr 19, 2019 | DISCN | No | No | ⤷ 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 |
