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Last Updated: October 30, 2020

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Citric acid; magnesium oxide; sodium picosulfate - Generic Drug Details

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What are the generic drug sources for citric acid; magnesium oxide; sodium picosulfate and what is the scope of patent protection?

Citric acid; magnesium oxide; sodium picosulfate is the generic ingredient in two branded drugs marketed by Ferring Pharms Inc and is included in two NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Citric acid; magnesium oxide; sodium picosulfate has forty-three patent family members in twenty-four countries.

There are five drug master file entries for citric acid; magnesium oxide; sodium picosulfate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for citric acid; magnesium oxide; sodium picosulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hospital Universitari Vall d'Hebron Research InstitutePhase 4
Ferring PharmaceuticalsPhase 4
The Cleveland ClinicPhase 4

See all citric acid; magnesium oxide; sodium picosulfate clinical trials

Generic filers with tentative approvals for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Tradename Dosage Ingredient NDA Submissiondate
CLENPIQ SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 209589 2019-02-11
PREPOPIK FOR SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 202535 2014-05-21

US Patents and Regulatory Information for citric acid; magnesium oxide; sodium picosulfate

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 PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   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
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 PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   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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