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.
Summary for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
International Patents: | 45 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 6 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE |
DailyMed Link: | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE at DailyMed |
Recent Clinical Trials for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
North Denmark Regional Hospital | Phase 4 |
Norgine | Phase 4 |
Aalborg University Hospital | Phase 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 Up | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | FOR 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.
Pharmacology 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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