Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: August 18, 2017
What are the generic drug sources for fenofibrate and what is the scope of fenofibrate freedom to operate?
Fenofibrate is the generic ingredient in nine branded drugs marketed by Abbott, Abbvie, Cipla Ltd, Impax Labs, Cipher Pharms Inc, Valeant Pharms North, Aurobindo Pharma Ltd, Santarus Inc, Lupin Ltd, Mylan, Rhodes Pharms, Sun Pharm Inds Ltd, Skyepharma Ag, Apotex Inc, Mylan Pharms Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Lupin Atlantis, and Hetero Labs Ltd Iii, and is included in twenty-eight NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 9 |
| Patents: | 18 |
| Applicants: | 20 |
| NDAs: | 28 |
| Drug Master File Entries: see list | 42 |
| Suppliers / Packagers: see list | 53 |
| Bulk Api Vendors: see list | 80 |
| Clinical Trials: see list | 138 |
| Patent Applications: see list | 6,493 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | fenofibrate at DailyMed |
| Ingredient-type | PPAR alpha |
| Drug Class | Peroxisome Proliferator Receptor alpha Agonist |
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 43MG | CAPSULE; ORAL |
| ► Subscribe | ► Subscribe | 130MG | CAPSULE; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Pharms Inc | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 202676-001 | Oct 23, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Santarus Inc | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Mylan Pharms Inc | FENOFIBRATE | fenofibrate | TABLET;ORAL | 202856-001 | Dec 7, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | |||||||||||||||
Abbott | TRICOR | fenofibrate | TABLET;ORAL | 021203-001 | Sep 4, 2001 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-003 | Jan 11, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbvie | TRICOR | fenofibrate | TABLET;ORAL | 021656-002 | Nov 5, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbvie | TRICOR (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 019304-003 | Jun 30, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbott | TRICOR | fenofibrate | TABLET;ORAL | 021203-001 | Sep 4, 2001 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,703,202 | Coated tablets | ► Subscribe | |||||||||||||||||||||||||||
| 7,931,917 | Nanoparticulate fibrate formulations | ► Subscribe | |||||||||||||||||||||||||||
| 7,198,795 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions | ► Subscribe | |||||||||||||||||||||||||||
| 8,323,641 | Nanoparticulate compositions having lysozyme as a surface stabilizer | ► Subscribe | |||||||||||||||||||||||||||
| 6,596,317 | Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2003511406 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2014091318 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60332212 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2492488 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | PI0414860 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
Follow DrugPatentWatch:
Join the 22,350 others who get our Drug Patent Expiration Alerts:
