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Generated: June 26, 2017
What are the generic sources for gemfibrozil and what is the scope of gemfibrozil freedom to operate?
Gemfibrozil is the generic ingredient in two branded drugs marketed by Impax Pharms, Caribe Holdings, Sandoz, Pfizer Pharms, Aurobindo Pharma Ltd, Purepac Pharm, Apotex, Invagen Pharms, Sun Pharm Inds Inc, Watson Labs, Mylan, Teva, Cadila Pharms Ltd, Chartwell Molecules, Northstar Hlthcare, and Hikma Pharms, and is included in nineteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 1 |
| Applicants: | 16 |
| NDAs: | 19 |
| Drug Master File Entries: see list | 20 |
| Suppliers / Packagers: see list | 49 |
| Bulk Api Vendors: see list | 69 |
| Clinical Trials: see list | 32 |
| Patent Applications: see list | 5,600 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | gemfibrozil 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 | 300MG | CAPSULE;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Inc | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 079239-001 | Dec 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sandoz | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074615-001 | Sep 29, 1995 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Impax Pharms | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 078207-001 | Jun 1, 2007 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Invagen Pharms | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 077836-001 | Jul 27, 2006 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cadila Pharms Ltd | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 203266-001 | Jun 17, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer Pharms | LOPID | gemfibrozil | CAPSULE;ORAL | 018422-001 | Approved Prior to Jan 1, 1982 | 3,674,836 | ► Subscribe | ||||||||||||||||||||||
Pfizer Pharms | LOPID | gemfibrozil | CAPSULE;ORAL | 018422-002 | Approved Prior to Jan 1, 1982 | 3,674,836 | ► Subscribe | ||||||||||||||||||||||
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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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