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Last Updated: March 28, 2024

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 freedom to operate?

Citric acid; magnesium oxide; sodium picosulfate is the generic ingredient in three branded drugs marketed by Ferring Pharms Inc and Hetero Labs Ltd V, and is included in three NDAs. There are five 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-five patent family members in twenty-five countries.

Two suppliers are 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
NorginePhase 4
Aalborg University HospitalPhase 4
North Denmark Regional HospitalPhase 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
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
CLENPIQ Oral Solution citric acid; magnesium oxide; sodium picosulfate 10 mg, 3.5 g, and 12 g 209589 1 2019-02-11
PREPOPIK Oral Solution citric acid; magnesium oxide; sodium picosulfate 10 mg, 3.5 g, and 12 g 202535 1 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 CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hetero Labs Ltd V SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 212789-001 Jul 18, 2022 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for citric acid; magnesium oxide; sodium picosulfate

Country Patent Number Title Estimated Expiration
Hungary E038174 ⤷  Try a Trial
Taiwan 200924759 Process for the manufacture of a pharmaceutical product ⤷  Try a Trial
South Korea 20100072020 PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.