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, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, 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, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Salix, and Skyepharma Ag, and is included in fifty-three NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fenofibrate has thirty-one patent family members in twelve 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: | 31 |
US Patents: | 6 |
Tradenames: | 9 |
Applicants: | 38 |
NDAs: | 53 |
Drug Master File Entries: | 42 |
Finished Product Suppliers / Packagers: | 51 |
Raw Ingredient (Bulk) Api Vendors: | 138 |
Clinical Trials: | 182 |
Patent Applications: | 6,868 |
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 |
---|---|
Lindsay Ferguson, MD | Phase 1 |
Tanta University | Phase 4 |
Han Ying | Phase 2/Phase 3 |
Generic filers with tentative approvals for FENOFIBRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 130MG | CAPSULE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rhodes Pharms | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076433-002 | May 13, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Torrent | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210782-003 | Jun 26, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-002 | Aug 10, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Prinston Inc | FENOFIBRATE | fenofibrate | TABLET;ORAL | 211080-002 | Aug 28, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | FENOFIBRATE | fenofibrate | TABLET;ORAL | 205118-002 | May 5, 2016 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Austarpharma | FENOFIBRATE | fenofibrate | TABLET;ORAL | 207803-002 | Dec 19, 2017 | 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 |
Expired US Patents for fenofibrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021203-001 | Sep 4, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Skyepharma Ag | TRIGLIDE | fenofibrate | TABLET;ORAL | 021350-002 | May 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-001 | Nov 5, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fenofibrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006037347 | ⤷ Sign Up | |
Japan | 5069001 | ⤷ Sign Up | |
Russian Federation | 2006115596 | ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН | ⤷ Sign Up |
European Patent Office | 1804768 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN) | ⤷ Sign Up |
Japan | 2007508249 | ⤷ Sign Up | |
Australia | 2009201881 | A solid dosage form comprising a fibrate and a statin | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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