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-three 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: | 33 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 43 |
Patent Applications: | 7,282 |
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 |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074442-001 | Apr 28, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Invagen Pharms | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 077836-001 | Jul 27, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 075034-001 | Jul 20, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Watson Labs | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074156-001 | Oct 24, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Purepac Pharm | GEMFIBROZIL | gemfibrozil | CAPSULE;ORAL | 072929-001 | Jan 29, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer Pharms | LOPID | gemfibrozil | CAPSULE;ORAL | 018422-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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