Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018422

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NDA 018422 describes LOPID, which is a drug marketed by Pfizer Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the LOPID profile page.

The generic ingredient in LOPID is gemfibrozil. Thirty-four suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.
Summary for 018422
Tradename:LOPID
Applicant:Pfizer Pharms
Ingredient:gemfibrozil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018422
Medical Subject Heading (MeSH) Categories for 018422
Suppliers and Packaging for NDA: 018422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPID gemfibrozil CAPSULE;ORAL 018422 NDA Parke-Davis Div of Pfizer Inc 0071-0737 0071-0737-20 60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20)
LOPID gemfibrozil CAPSULE;ORAL 018422 NDA Parke-Davis Div of Pfizer Inc 0071-0737 0071-0737-30 500 TABLET, FILM COATED in 1 BOTTLE (0071-0737-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Nov 20, 1986TE:ABRLD:Yes

Expired US Patents for NDA 018422

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   Start Trial   Start Trial
Pfizer Pharms LOPID gemfibrozil CAPSULE;ORAL 018422-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Colorcon
Express Scripts
Medtronic
AstraZeneca

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