Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate - Generic Drug Details
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What are the generic drug sources for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate and what is the scope of freedom to operate?
Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
is the generic ingredient in three branded drugs marketed by Novel Labs Inc and Salix Pharms, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate has twenty-nine patent family members in eleven countries.
Summary for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
International Patents: | 29 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
DailyMed Link: | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate at DailyMed |
Pharmacology for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Drug Class | Osmotic Laxative |
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Paragraph IV (Patent) Challenges for SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OSMOPREP | Tablets | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | 1.102 g and 0.398 g | 021892 | 1 | 2008-04-09 |
US Patents and Regulatory Information for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novel Labs Inc | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 079247-001 | Dec 30, 2011 | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Salix Pharms | OSMOPREP | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021892-001 | Mar 16, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Salix Pharms | VISICOL | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021097-001 | Sep 21, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix Pharms | OSMOPREP | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021892-001 | Mar 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Salix Pharms | VISICOL | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021097-001 | Sep 21, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2012216409 | Colonic purgative composition with soluble binding agent | ⤷ Try a Trial |
South Korea | 20060114342 | COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT | ⤷ Try a Trial |
South Korea | 20120045015 | COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0268956 | SPC/GB98/040 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508 |
2673237 | LUC00111 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326 |
2380576 | 20C1048 | France | ⤷ Try a Trial | PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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