➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
McKinsey
Harvard Business School
Moodys
McKesson

Last Updated: October 29, 2020

DrugPatentWatch Database Preview

Fenofibrate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, Aurobindo Pharma Ltd, Cipla, Dr Reddys, 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-nine patent family members in forty-six countries.

There are forty-two drug master file entries for fenofibrate. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for fenofibrate

See drug prices for fenofibrate

Drug Sales Revenue Trends for fenofibrate

See drug sales revenues for fenofibrate

Recent Clinical Trials for fenofibrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rehab WeridaPhase 4
Singapore General HospitalPhase 3
National Medical Research Council (NMRC), SingaporePhase 3

See all fenofibrate clinical trials

Generic filers with tentative approvals for FENOFIBRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial130MGCAPSULE; ORAL
  Start Trial  Start Trial43MGCAPSULE; 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
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 (MICRONIZED) CAPSULE;ORAL fenofibrate 019304
TRICOR TABLET;ORAL fenofibrate 021203
LIPIDIL 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
Ajanta Pharma Ltd FENOFIBRATE fenofibrate TABLET;ORAL 210138-001 Jul 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Atlantis ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Mankind Pharma FENOFIBRATE fenofibrate TABLET;ORAL 213864-001 Jun 12, 2020 AB RX 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 fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Mallinckrodt
Dow
Colorcon
McKinsey

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.