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Last Updated: January 17, 2021

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RESCULA Drug Profile

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When do Rescula patents expire, and when can generic versions of Rescula launch?

Rescula is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in eighteen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Rescula

Rescula was eligible for patent challenges on August 3, 2004.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 9, 2021. This may change due to patent challenges or generic licensing.

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

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Summary for RESCULA
International Patents:21
US Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: 21
Patent Applications: 544
DailyMed Link:RESCULA at DailyMed
Drug patent expirations by year for RESCULA
Generic Entry Opportunity Date for RESCULA
Generic Entry Date for RESCULA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for RESCULA
Tradename Dosage Ingredient NDA Submissiondate
RESCULA SOLUTION/DROPS;OPHTHALMIC unoprostone isopropyl 021214 2014-05-12

US Patents and Regulatory Information for RESCULA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 DISCN Yes No   Start Trial   Start Trial   Start 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 RESCULA

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

Supplementary Protection Certificates for RESCULA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0289349 300135 Netherlands   Start Trial 300135, 20080429, EXPIRES: 20130428
0289349 SPC/GB04/007 United Kingdom   Start Trial PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112
0289349 C300135 Netherlands   Start Trial PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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