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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, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms 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 Labs, Amneal, Aurobindo Pharma Ltd, 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-eight NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fenofibrate has two hundred and thirty-five patent family members in thirty-one countries.
There are forty-two drug master file entries for fenofibrate. Fifty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FENOFIBRATE
| International Patents: | 235 |
| US Patents: | 9 |
| Tradenames: | 9 |
| Applicants: | 33 |
| NDAs: | 48 |
| Drug Master File Entries: | 42 |
| Finished Product Suppliers / Packagers: | 54 |
| Raw Ingredient (Bulk) Api Vendors: | 126 |
| Clinical Trials: | 155 |
| Patent Applications: | 6,922 |
| 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 Institutes of Health (NIH) | Phase 3 |
| Roche Pharma AG | Phase 3 |
| Juvenile Diabetes Research Foundation | Phase 3 |
Generic filers with tentative approvals for FENOFIBRATE
| Applicant | Application No. | Strength | Dosage Form |
| Get Started for $10 | Get Started for $10 | 130MG | CAPSULE; ORAL |
| Get Started for $10 | Get Started for $10 | 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 |
| LIPIDIL | CAPSULE;ORAL | fenofibrate | 019304 | |
| TRICOR (MICRONIZED) | CAPSULE;ORAL | fenofibrate | 019304 | |
| TRICOR | TABLET;ORAL | fenofibrate | 021203 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 075868-002 | Oct 27, 2003 | AB | RX | No | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Dr Reddys | FENOFIBRATE | fenofibrate | TABLET;ORAL | 210670-001 | Sep 6, 2019 | AB | RX | No | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Austarpharma | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 207805-003 | Nov 16, 2017 | AB | RX | No | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Torrent | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210782-001 | Jun 26, 2018 | AB | RX | No | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Lupin Ltd | FENOFIBRATE | fenofibrate | TABLET;ORAL | 090856-001 | Dec 23, 2011 | AB | RX | No | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| >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 | 019304-002 | Feb 9, 1998 | Get Started for $10 | Get Started for $10 |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | Get Started for $10 | Get Started for $10 |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | Get Started for $10 | Get Started for $10 |
| Abbvie Inc | TRICOR | fenofibrate | TABLET;ORAL | 021203-001 | Sep 4, 2001 | Get Started for $10 | Get Started for $10 |
| Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FENOFIBRATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2228060 | Get Started for $10 |
| Australia | 6283299 | Get Started for $10 |
| European Patent Office | 1320362 | Get Started for $10 |
| Canada | 2582403 | Get Started for $10 |
| European Patent Office | 1800666 | Get Started for $10 |
| >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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