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Last Updated: June 2, 2020

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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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for RESCULA
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.

Recent Litigation for RESCULA

Identify potential future generic entrants

District Court Litigation
Case NameDate
SUCAMPO AG v. TEVA PHARMACEUTICAL INDUSTRIES LTD.2017-09-25
Allergan, Inc. v. Sandoz, Inc.2015-10-19

See all RESCULA litigation

Synonyms for RESCULA
120373-24-2
373U242
5-Heptenoic acid, 7-((1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl)-, 1-methylethyl ester, (5Z)-
5M161S5O5P
AKOS015965062
C25H44O5
CAS-120373-24-2
CHEBI:31731
CHEMBL1200661
D01452
DSSTox_CID_28997
DSSTox_GSID_49071
DSSTox_RID_83262
DTXSID5049071
Eescula
GTPL8282
HMS3648F04
isopropyl (5Z,9alpha,11alpha)-9,11-dihydroxy-15-oxo-20a,20b-dihomoprost-5-en-1-oate
isopropyl (Z)-7-((1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl)hept-5-enoate
isopropyl 20-ethyl-9alpha,11alpha-dihydroxy-15-keto-cis-delta-5-prostanoate
isopropyl unoprostone
Isopropyl unoprostone (JAN)
isopropyl(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-{3-oxo-1-decyl}cyclopentyl]-hept-5-enoate
LS-176760
LS-74384
N919
NCGC00183877-01
Ocuseva
propan-2-yl (5Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl]hept-5-enoate
propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl]hept-5-enoate
Q27089094
Rescula (proposed trade name)
SCHEMBL192726
SR-01000946493
SR-01000946493-1
Tox21_113629
UF 021
UF 21 (urethane polymer)
UF-021
UF-21
UNII-5M161S5O5P
unoprostone isopropyl
Unoprostone isopropyl ester
XXUPXHKCPIKWLR-JHUOEJJVSA-N
ZINC14234780
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
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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Medtronic
Express Scripts
Johnson and Johnson
Dow

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 verification 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.