OSMOPREP Drug Patent 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. 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 |
---|---|
Bausch Health Americas, Inc. | Phase 4 |
Valeant Pharmaceuticals International, 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 | ⤷ Sign Up | ⤷ Sign Up |
>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 | 102648980 | Colonic purgative composition with soluble binding agent | ⤷ Sign Up |
Spain | 2584866 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 9741838 | ⤷ Sign Up | |
Argentina | 046651 | COMPOSICION PURGANTE COLONICA CON AGENTE AGLUTINANTE SOLUBLE | ⤷ Sign Up |
Australia | 2015221520 | COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT | ⤷ Sign Up |
Japan | 5329042 | ⤷ Sign Up | |
Australia | 2012202628 | Colonic purgative composition with soluble binding agent | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OSMOPREP
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2203431 | 2015/009 | Ireland | ⤷ Sign Up | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
1758590 | LUC00029 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
2822954 | 18C1035 | France | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
1912999 | 1490062-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
0806968 | SPC/GB07/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 |
1259550 | 08C0052 | France | ⤷ Sign Up | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
1874117 | SPC/GB14/041 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |