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RESCULA

NDA

UNOPROSTONE ISOPROPYL | N021214 | SUCAMPO PHARMA AMERICAS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Lachman Consultant Services, Inc. FDA-2014-P-0230 Lachman Consultant Services, Inc. filed this petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Rescula (Unoprostone Isopropyl Ophthalmic Solution, 15%), subject of NDA 021214 held by Sucampo Pharmaceuticals, as a reference listed drug to enabl	505(q)	2014-03-07	Granted	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration NCT01379560	Phase 2	Completed	Sucampo Pharma Americas, LLC	33	2011-05 → 2011-12
Phase III Efficacy and Safety Clinical Study of UF-021 for Treatment of Retinitis Pigmentosa NCT01786395	Phase 3	Terminated	R-Tech Ueno, Ltd.	202	2013-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF2 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHIROGATE INTERNATIONAL INCUNOPROSTONE ISOPROPYL

DMF 283392014

R TECH UENO LTDInactiveUNOPROSTONE ISOPROPYL

DMF 146111999

R TECH UENO LTDInactiveUNOPROSTONE ISOPROPYL OPHTHALMIC SOLUTION 0.15%

DMF 229872009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 3, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Aug 3, 2000

No patent or exclusivity listings for this strength.