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: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209589

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NDA 209589 describes CLENPIQ, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CLENPIQ profile page.

The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
Summary for 209589
Suppliers and Packaging for NDA: 209589
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589 NDA Ferring Pharmaceuticals Inc. 55566-6700 55566-6700-1 2 BOTTLE in 1 CARTON (55566-6700-1) > 160 mL in 1 BOTTLE (55566-6700-0)
Paragraph IV (Patent) Challenges for 209589
Tradename Dosage Ingredient NDA Submissiondate
CLENPIQ SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 209589 2019-02-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength12GM/BOT;3.5GM/BOT;10MG/BOT
Approval Date:Nov 28, 2017TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 26, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR CLEANSING THE LARGE INTESTINE AS A PREPARATION FOR COLONOSCOPY

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