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, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, and Torrent. and is included in forty-six NDAs.
The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for FENOFIBRATE?
- What are the global sales for FENOFIBRATE?
- What is Average Wholesale Price for FENOFIBRATE?
Summary for FENOFIBRATE
| US Patents: | 0 |
| Applicants: | 33 |
| NDAs: | 46 |
| Finished Product Suppliers / Packagers: | 45 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 182 |
| Patent Applications: | 3,866 |
| 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 |
|---|---|
| Lindsay Ferguson, MD | Phase 1 |
| Tanta University | Phase 4 |
| Han Ying | Phase 2/Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 202252-001 | Jul 26, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rhodes Pharms | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 075753-003 | Apr 9, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076520-003 | Oct 25, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impax Labs | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076509-002 | Mar 26, 2008 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impax Labs | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 075868-002 | Oct 27, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rhodes Pharms | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076433-002 | May 13, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
