FENOFIBRATE Drug Patent Profile
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When do Fenofibrate patents expire, and what generic alternatives are available?
Fenofibrate is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Sun Pharm, Valeant Pharms North, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, Reyoung, Rising, Torrent, and Youngtech Pharms Inc. and is included in forty-five NDAs.
The generic ingredient in FENOFIBRATE 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
A generic version of FENOFIBRATE was approved as fenofibrate by RHODES PHARMS on May 13th, 2005.
Summary for FENOFIBRATE
| US Patents: | 0 |
| Applicants: | 32 |
| NDAs: | 45 |
| Finished Product Suppliers / Packagers: | 41 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 179 |
| Patent Applications: | 3,830 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FENOFIBRATE |
| Drug Sales Revenues: | Drug sales revenues for FENOFIBRATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FENOFIBRATE |
| What excipients (inactive ingredients) are in FENOFIBRATE? | FENOFIBRATE excipients list |
| DailyMed Link: | FENOFIBRATE at DailyMed |
See drug prices for FENOFIBRATE
Recent Clinical Trials for FENOFIBRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University | Phase 2 |
| Tanta University | Phase 2 |
| Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University | Phase 2 |
Pharmacology for FENOFIBRATE
Medical Subject Heading (MeSH) Categories for FENOFIBRATE
Anatomical Therapeutic Chemical (ATC) Classes for FENOFIBRATE
Paragraph IV (Patent) Challenges for FENOFIBRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FENOGLIDE | Tablets | fenofibrate | 40 mg and 120 mg | 022118 | 1 | 2010-03-17 |
| ANTARA (MICRONIZED) | Capsules | fenofibrate | 43 mg and 130 mg | 021695 | 1 | 2008-09-15 |
| TRICOR | Tablets | fenofibrate | 48 mg | 021656 | 1 | 2008-07-01 |
| TRICOR | Tablets | fenofibrate | 145 mg | 021656 | 1 | 2007-10-19 |
US Patents and Regulatory Information for FENOFIBRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 212232-001 | Sep 20, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Torrent | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210782-002 | Jun 26, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mankind Pharma | FENOFIBRATE | fenofibrate | TABLET;ORAL | 213864-001 | Jun 12, 2020 | AB | RX | 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 |
