UNOPROSTONE ISOPROPYL - Generic Drug Details

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What are the generic sources for unoprostone isopropyl and what is the scope of freedom to operate?

Unoprostone isopropyl is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for unoprostone isopropyl.

Summary for UNOPROSTONE ISOPROPYL

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	1
Patent Applications:	2,098
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UNOPROSTONE ISOPROPYL
DailyMed Link:	UNOPROSTONE ISOPROPYL at DailyMed

Recent Clinical Trials for UNOPROSTONE ISOPROPYL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sucampo Pharma Americas, LLC	Phase 2
Sucampo Pharmaceuticals, Inc.	Phase 2

See all UNOPROSTONE ISOPROPYL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for UNOPROSTONE ISOPROPYL

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for UNOPROSTONE ISOPROPYL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESCULA	Ophthalmic Solution	unoprostone isopropyl	0.15%	021214	1	2014-05-12

US Patents and Regulatory Information for UNOPROSTONE ISOPROPYL

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 UNOPROSTONE ISOPROPYL

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

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