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Last Updated: November 22, 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 patent protection?

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
North Denmark Regional HospitalPhase 4
NorginePhase 4
Aalborg University 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
⤷  Sign Up⤷  Sign Up12GM/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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Japan 2017508815 液状医薬組成物 ⤷  Sign Up
Denmark 2207526 ⤷  Sign Up
Saudi Arabia 08290670 عملية تصنيع خاصة بمنتج صيدلاني من بيكوكبريتات الصوديوم (Manufacturing Process for a Pharmaceutical Sodium Picosulphate Product) ⤷  Sign Up
European Patent Office 2207526 PROCÉDÉ DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE CONTENANT DE L'ACIDE CITRIQUE, DE L'OXYDE DE MAGNÉSIUM, DU BICARBONATE DE POTASSIUM ET DU PICOSULFATE DE SODIUM, COMPOSITION PHARMACEUTIQUE CONTENANT DES GRANULES ET LEUR PRODUIT INTERMEDIAIRE (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF) ⤷  Sign Up
New Zealand 583899 PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE ⤷  Sign Up
Russian Federation 2668882 Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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