Serving leading biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving leading biopharmaceutical companies globally:
Generated: October 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 Abbvie Inc, 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-nine NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| US Patents: | 18 |
| Tradenames: | 9 |
| Applicants: | 20 |
| NDAs: | 29 |
| Drug Master File Entries: see list | 42 |
| Suppliers / Packagers: see list | 54 |
| Bulk Api Vendors: see list | 80 |
| Clinical Trials: see list | 138 |
| Patent Applications: see list | 5,802 |
| 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 |
| u | ► Subscribe | 43MG | CAPSULE; ORAL |
| u | ► Subscribe | 130MG | CAPSULE; ORAL |
Export unavailable in trial.
Subscribe for complete access.
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,459,283 | Nanoparticulate compositions having lysozyme as a surface stabilizer | ► Subscribe | |||||||||||||
| 7,198,795 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions | ► Subscribe | |||||||||||||
| 7,521,068 | Dry powder aerosols of nanoparticulate drugs | ► Subscribe | |||||||||||||
| 8,124,057 | Propellant-based nanoparticulate dry powder aerosols and method of making | ► Subscribe | |||||||||||||
| 6,596,317 | Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it | ► Subscribe | |||||||||||||
| 8,652,464 | Method of treatment using nanoparticulate compositions having lysozyme as a surface stabilizer | ► Subscribe | |||||||||||||
| 6,316,029 | Rapidly disintegrating solid oral dosage form | ► Subscribe | |||||||||||||
| 8,658,212 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ► Subscribe | |||||||||||||
| 7,931,917 | Nanoparticulate fibrate formulations | ► Subscribe | |||||||||||||
| 8,293,277 | Controlled-release nanoparticulate compositions | ► 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 | 2010018604 | ► Subscribe | |||||||||||||
| Taiwan | I354568 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 0126635 | ► Subscribe | |||||||||||||
| European Patent Office | 1273294 | ► Subscribe | |||||||||||||
| European Patent Office | 1282399 | ► Subscribe | |||||||||||||
| European Patent Office | 1320362 | ► Subscribe | |||||||||||||
| Germany | 602004020641 | ► Subscribe | |||||||||||||
| Hungary | 227758 | ► Subscribe | |||||||||||||
| South Korea | 20110116252 | ► Subscribe | |||||||||||||
| Argentina | 040110 | ► 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 leading 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 22,931 others who get our Drug Patent Expiration Alerts:
