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FENOFIBRATE - Generic Drug Details
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What are the generic drug sources for fenofibrate and what is the scope of freedom to operate?
Fenofibrate
is the generic ingredient in nine branded drugs marketed by Lupin Atlantis, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Ani Pharms Inc, Apotex, Austarpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Rhodes Pharms, Torrent, Abbvie, Cipher Pharms Inc, Alembic Pharms Ltd, Amneal Pharms Llc, Appco, Aurobindo Pharma Ltd, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Orit Labs Llc, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in forty-six NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fenofibrate has three hundred and twenty-eight patent family members in forty-six countries.
There are forty-two drug master file entries for fenofibrate. Fifty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FENOFIBRATE
| International Patents: | 328 |
| US Patents: | 12 |
| Tradenames: | 9 |
| Applicants: | 33 |
| NDAs: | 46 |
| Drug Master File Entries: | 42 |
| Suppliers / Packagers: | 55 |
| Bulk Api Vendors: | 117 |
| Clinical Trials: | 152 |
| Patent Applications: | 6,553 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for FENOFIBRATE |
| Drug Sales Revenues: | Drug sales revenues for FENOFIBRATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FENOFIBRATE |
| DailyMed Link: | FENOFIBRATE at DailyMed |
Recent Clinical Trials for FENOFIBRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Medical Research Council (NMRC), Singapore | Phase 3 |
| Singapore General Hospital | Phase 3 |
| Medical University of South Carolina | Phase 4 |
Generic filers with tentative approvals for FENOFIBRATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 130MG | CAPSULE; ORAL |
| Start Trial | Start Trial | 43MG | CAPSULE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for FENOFIBRATE
| Drug Class | Peroxisome Proliferator Receptor alpha Agonist |
Medical Subject Heading (MeSH) Categories for FENOFIBRATE
Paragraph IV (Patent) Challenges for FENOFIBRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FENOGLIDE | TABLET;ORAL | fenofibrate | 022118 | 2010-03-17 |
| ANTARA (MICRONIZED) | CAPSULE;ORAL | fenofibrate | 021695 | 2008-09-15 |
| TRICOR | TABLET;ORAL | fenofibrate | 021656 | 2008-07-01 |
| TRICOR | TABLET;ORAL | fenofibrate | 021656 | 2007-10-19 |
| TRICOR | TABLET;ORAL | fenofibrate | 021203 | |
| LIPIDIL | CAPSULE;ORAL | fenofibrate | 019304 | |
| TRICOR (MICRONIZED) | CAPSULE;ORAL | fenofibrate | 019304 |
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 | Start Trial | Start Trial | Start Trial | |||
| Novast Labs | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207564-003 | Apr 19, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ajanta Pharma Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705-002 | Sep 10, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Pharms Inc | FENOFIBRATE | fenofibrate | TABLET;ORAL | 202856-002 | Dec 7, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Valeant Pharms North | FENOFIBRATE | fenofibrate | TABLET;ORAL | 090715-002 | Apr 5, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-002 | Jan 11, 2006 | DISCN | No | No | Start Trial | Start Trial | 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 FENOFIBRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-001 | Nov 5, 2004 | Start Trial | Start Trial |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-001 | Nov 5, 2004 | Start Trial | Start Trial |
| Abbvie | TRICOR (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 019304-002 | Feb 9, 1998 | Start Trial | Start Trial |
| Abbvie Inc | TRICOR | fenofibrate | TABLET;ORAL | 021203-003 | Sep 4, 2001 | Start Trial | Start Trial |
| Abbvie | LIPIDIL | fenofibrate | CAPSULE;ORAL | 019304-001 | Dec 31, 1993 | Start Trial | Start Trial |
| Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FENOFIBRATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101216853 | Start Trial |
| New Zealand | 587658 | Start Trial |
| Canada | 2541382 | Start Trial |
| Australia | 2003261167 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009120919 | Start Trial |
| European Patent Office | 1574214 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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