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#001 — 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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