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Generated: May 25, 2019

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OSMOPREP Drug Profile

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Which patents cover Osmoprep, and what generic alternatives are available?

Osmoprep is a drug marketed by Salix Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in eleven countries.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.

US Patents and Regulatory Information for OSMOPREP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892-001 Mar 16, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for OSMOPREP
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 1.102 g and 0.398 g ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for OSMOPREP

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203431 15C0013 France ➤ Try a Free Trial PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
0473687 SPC/GB98/030 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
1948158 1690020-1 Sweden ➤ Try a Free Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
2822954 LUC00083 Luxembourg ➤ Try a Free Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Federal Trade Commission
Harvard Business School
Cantor Fitzgerald
Colorcon
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McKesson

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