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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021214

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NDA 021214 describes RESCULA, which is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RESCULA profile page.

The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for 021214

Tradename:	RESCULA
Applicant:	Sucampo Pharma Llc
Ingredient:	unoprostone isopropyl
Patents:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.15% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Aug 3, 2000	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jul 9, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING OCULAR HYPERTENSION
Patent:	➤ Sign Up	Patent Expiration:	Jul 9, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND GLAUCOMA
Patent:	➤ Sign Up	Patent Expiration:	Nov 24, 2018	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF REDUCING OCULAR HYPERTENSION

Expired US Patents for NDA 021214

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	➤ Sign Up	➤ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	➤ Sign Up	➤ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	➤ Sign Up	➤ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.