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, Adaptis, Alembic Labs, Amneal, 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 forty-nine 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-two 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: | 49 |
Drug Master File Entries: | 42 |
Finished Product Suppliers / Packagers: | 52 |
Raw Ingredient (Bulk) Api Vendors: | 129 |
Clinical Trials: | 170 |
Patent Applications: | 7,515 |
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 |
---|---|
Seoul National University Bundang Hospital | Phase 4 |
University of Minnesota | Phase 2 |
University of Michigan | Phase 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076520-003 | Oct 25, 2007 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Dr Reddys | FENOFIBRATE | fenofibrate | TABLET;ORAL | 210670-001 | Sep 6, 2019 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Graviti Pharms | FENOFIBRATE | fenofibrate | TABLET;ORAL | 211122-002 | Mar 18, 2020 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Invagen Pharms | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207378-001 | Mar 28, 2017 | 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 | TRICOR (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 019304-003 | Jun 30, 1999 | See Plans and Pricing | See Plans and Pricing |
Abbvie | TRICOR (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 019304-004 | Jun 30, 1999 | See Plans and Pricing | See Plans and Pricing |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FENOFIBRATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 072134 | COMPOSICIONES DE NANOPARTICULAS DE INHIBIDORES DE ANGIOGENESIS | See Plans and Pricing |
Japan | 4842514 | See Plans and Pricing | |
European Patent Office | 1471887 | COMPOSITIONS NANOPARTICULAIRES A STABILISATEUR SUPERFICIEL DE LYSOZYME (NANOPARTICULATE COMPOSITIONS HAVING LYSOZYME AS A SURFACE STABILIZER) | See Plans and Pricing |
Denmark | 2263652 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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