Viewing data from:

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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#001 — 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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