Gemfibrozil - Generic Drug Details
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What are the generic sources for gemfibrozil and what is the scope of freedom to operate?
Gemfibrozil
is the generic ingredient in two branded drugs marketed by Mylan, Purepac Pharm, Pfizer Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Chartwell Rx, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.Thirty-two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for gemfibrozil
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 18 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 135 |
| Clinical Trials: | 41 |
| Patent Applications: | 6,788 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for gemfibrozil |
| Drug Sales Revenues: | Drug sales revenues for gemfibrozil |
| What excipients (inactive ingredients) are in gemfibrozil? | gemfibrozil excipients list |
| DailyMed Link: | gemfibrozil at DailyMed |
Recent Clinical Trials for gemfibrozil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Louis University | Early Phase 1 |
| Polaryx Therapeutics, Inc. | Phase 3 |
| Bristol-Myers Squibb | Phase 1 |
Generic filers with tentative approvals for GEMFIBROZIL
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 300MG | 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 gemfibrozil
| Drug Class | Peroxisome Proliferator Receptor alpha Agonist |
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for gemfibrozil
Anatomical Therapeutic Chemical (ATC) Classes for gemfibrozil
US Patents and Regulatory Information for gemfibrozil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma Pharms | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 078599-001 | Aug 16, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 202726-001 | Sep 16, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Impax Pharms | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 078207-001 | Jun 1, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Watson Labs | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074156-001 | Oct 24, 1994 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Purepac Pharm | GEMFIBROZIL | gemfibrozil | CAPSULE;ORAL | 072929-001 | Jan 29, 1993 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Inds Inc | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 079239-001 | Dec 29, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 gemfibrozil
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer Pharms | LOPID | gemfibrozil | CAPSULE;ORAL | 018422-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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