OSMOPREP Drug Patent Profile
✉ Email this page to a colleague
When do Osmoprep patents expire, and when can generic versions of Osmoprep launch?
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. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.
DrugPatentWatch® Generic Entry Outlook for Osmoprep
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for OSMOPREP
International Patents: | 29 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Clinical Trials: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OSMOPREP |
Drug Sales Revenues: | Drug sales revenues for OSMOPREP |
What excipients (inactive ingredients) are in OSMOPREP? | OSMOPREP excipients list |
DailyMed Link: | OSMOPREP at DailyMed |
Recent Clinical Trials for OSMOPREP
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Valeant Pharmaceuticals International, Inc. | Phase 4 |
Bausch Health Americas, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for OSMOPREP
Paragraph IV (Patent) Challenges for OSMOPREP
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 OSMOPREP
OSMOPREP is protected by one US patents.
Patents protecting OSMOPREP
Colonic purgative composition with soluble binding agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 OSMOPREP
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OSMOPREP
See the table below for patents covering OSMOPREP around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 101087593 | Colonic purgative composition with soluble binding agent | ⤷ Try a Trial |
Australia | 2012216409 | Colonic purgative composition with soluble binding agent | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 9741838 | ⤷ Try a Trial | |
South Korea | 20060114342 | COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT | ⤷ Try a Trial |
South Korea | 101495690 | ⤷ Try a Trial | |
South Korea | 101268559 | ⤷ Try a Trial | |
Austria | 235894 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OSMOPREP
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0579826 | SPC/GB02/042 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422 |
1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
0480717 | 98C0022 | France | ⤷ Try a Trial | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
1948158 | 16C0018 | France | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
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 |
1856135 | 2090014-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
2822954 | 1890030-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |