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Generated: June 24, 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 nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 9 |
| Patents: | 19 |
| Applicants: | 20 |
| NDAs: | 28 |
| Drug Master File Entries: see list | 42 |
| Suppliers / Packagers: see list | 51 |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbott | TRICOR | fenofibrate | TABLET;ORAL | 021203-003 | Sep 4, 2001 | DISCN | Yes | No | 6,589,552 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbott | TRICOR | fenofibrate | TABLET;ORAL | 021203-003 | Sep 4, 2001 | DISCN | Yes | No | 7,037,529 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Glenmark Pharms Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 205566-001 | Apr 7, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Santarus Inc | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | AB | RX | Yes | No | 7,658,944 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Impax Labs | FENOFIBRATE | fenofibrate | TABLET;ORAL | 076509-001 | Mar 26, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | TRICOR (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 019304-003 | Jun 30, 1999 | 4,895,726 | ► Subscribe | ||||||||||||||||||||||
Abbott | TRICOR | fenofibrate | TABLET;ORAL | 021203-003 | Sep 4, 2001 | 4,895,726 | ► Subscribe | ||||||||||||||||||||||
Abbott | TRICOR | fenofibrate | TABLET;ORAL | 021203-001 | Sep 4, 2001 | 4,895,726 | ► Subscribe | ||||||||||||||||||||||
Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | 4,800,079 | ► Subscribe | ||||||||||||||||||||||
Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612-003 | Jan 11, 2006 | 5,545,628 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,592,903 | Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate | ► Subscribe | |||||||||||||||||||||||||||
| 6,969,529 | Nanoparticulate compositions comprising copolymers of vinyl pyrrolidone and vinyl acetate as surface stabilizers | ► Subscribe | |||||||||||||||||||||||||||
| 7,695,739 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions | ► Subscribe | |||||||||||||||||||||||||||
| 6,534,088 | Fibrate-statin combinations with reduced fed-fasted effects | ► Subscribe | |||||||||||||||||||||||||||
| 8,586,094 | Coated tablets | ► Subscribe | |||||||||||||||||||||||||||
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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.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 4841092 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2440355 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 731964 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2372561 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2005206614 | ► Subscribe | |||||||||||||||||||||||||||
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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.
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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.
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