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, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, 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, Abbvie, Cipher Pharms Inc, Alembic Labs, Amneal, Aurobindo Pharma, Austarpharma, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in fifty NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fenofibrate has one hundred and ninety-five patent family members in thirty countries.
There are forty-two drug master file entries for fenofibrate. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for fenofibrate
International Patents: | 195 |
US Patents: | 8 |
Tradenames: | 9 |
Applicants: | 36 |
NDAs: | 50 |
Drug Master File Entries: | 42 |
Finished Product Suppliers / Packagers: | 51 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 173 |
Patent Applications: | 6,916 |
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 |
What excipients (inactive ingredients) are in fenofibrate? | fenofibrate excipients list |
DailyMed Link: | fenofibrate at DailyMed |
Recent Clinical Trials for fenofibrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 4 |
University of Colorado, Denver | Phase 4 |
Mario Luca Morieri | N/A |
Generic filers with tentative approvals for FENOFIBRATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 130MG | CAPSULE; ORAL |
See Plans and Pricing | See Plans and Pricing | 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 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Sa | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 090859-002 | Mar 1, 2012 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Abbvie | TRICOR (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 019304-002 | Feb 9, 1998 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Mylan | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076520-002 | Dec 29, 2005 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Prinston Inc | FENOFIBRATE | fenofibrate | TABLET;ORAL | 211080-002 | Aug 28, 2018 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 Inc | TRICOR | fenofibrate | TABLET;ORAL | 021203-001 | Sep 4, 2001 | See Plans and Pricing | See Plans and Pricing |
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-003 | Jan 11, 2006 | See Plans and Pricing | See Plans and Pricing |
Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-001 | Nov 5, 2004 | See Plans and Pricing | See Plans and Pricing |
Abbvie Inc | TRICOR | fenofibrate | TABLET;ORAL | 021203-003 | Sep 4, 2001 | See Plans and Pricing | See Plans and Pricing |
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-001 | Jan 11, 2006 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fenofibrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200403079 | Nanoparticulate fibrate formulations | See Plans and Pricing |
China | 1867321 | A solid dosage form comprising a fibrate | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2005034920 | See Plans and Pricing | |
Japan | 2010280685 | NANOPARTICULATE COMPOSITION OF MAP KINASE INHIBITOR | See Plans and Pricing |
Canada | 2719811 | FORMES GALENIQUES DE FENOFIBRATE (FENOFIBRATE DOSAGE FORMS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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