Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate - Generic Drug Details
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What are the generic 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 | 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 | ||||
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 | ||
>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 |
---|---|---|---|
Brazil | 122014001142 | Formulação purgativa colônica, kit, método de purgar o cólon de um paciente, e, processo de produzir a formulação purgativa colônica | ⤷ Try a Trial |
South Korea | 101495690 | ⤷ Try a Trial | |
Spain | 2584866 | ⤷ Try a Trial | |
Japan | 2007512336 | ⤷ Try a Trial | |
China | 101087593 | Colonic purgative composition with soluble binding agent | ⤷ Try a Trial |
China | 102648980 | Colonic purgative composition with soluble binding agent | ⤷ Try a Trial |
South Korea | 20130048790 | 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 |
---|---|---|---|---|
1912999 | 1490062-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
2932970 | SPC/GB18/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518 |
2822954 | LUC00083 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
1856135 | SPC/GB20/016 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
2203431 | 2015/009 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
0579826 | 02C0041 | France | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
3141251 | 301099 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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