OSMOPREP Drug Patent Profile

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
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

See drug prices for OSMOPREP

See drug sales revenues for OSMOPREP

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

See all OSMOPREP clinical trials

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

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			Y	Y

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

International Patents for OSMOPREP

See the table below for patents covering OSMOPREP around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5329042
European Patent Office	2308476	Composition purgative pour le colon à agent de liaison soluble (Colonic purgative composition with soluble binding agent)
China	101087593	Colonic purgative composition with soluble binding agent
South Korea	20060114342	COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT
Canada	2241445	PREPARATIONS PURGATIVES NON AQUEUSES POUR LE COLON (NON-AQUEOUS COLONIC PURGATIVE FORMULATIONS)

Supplementary Protection Certificates for OSMOPREP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
1713823	92595	Luxembourg		PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
2673237	LUC00111	Luxembourg		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
1499331	SPC/GB13/034	United Kingdom		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