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Boehringer Ingelheim

Last Updated: January 20, 2021

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CLENPIQ Drug Profile

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When do Clenpiq patents expire, and what generic alternatives are available?

Clenpiq is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in nine countries.

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.

US ANDA Litigation and Generic Entry Outlook for Clenpiq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 23, 2034. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for CLENPIQ
Drug Prices for CLENPIQ

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Generic Entry Opportunity Date for CLENPIQ
Generic Entry Date for CLENPIQ*:
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.

Recent Clinical Trials for CLENPIQ

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Ferring PharmaceuticalsPhase 1/Phase 2

See all CLENPIQ clinical trials

Paragraph IV (Patent) Challenges for CLENPIQ
Tradename Dosage Ingredient NDA Submissiondate
CLENPIQ SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 209589 2019-02-11

US Patents and Regulatory Information for CLENPIQ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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