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Last Updated: April 14, 2021

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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 are two patents 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
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209589
Generic Entry Date for 209589*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 23, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 26, 2034Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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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.